Lidocaine 2% Topical Jelly 5ml
It is used to manage pain.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Local Anesthetic
Pharmacologic Class
Voltage-gated Sodium Channel Blocker
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lidocaine 2% Topical Jelly is a numbing medicine that helps to relieve pain or discomfort by temporarily blocking nerve signals in the area where it is applied. It's often used for procedures involving mucous membranes, like in the mouth, throat, or urinary tract.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication to your skin only, as instructed by your doctor. Do not take it by mouth.
Avoid getting this medication in your mouth, nose, or eyes, as it may cause burning. If you accidentally get it in any of these areas, rinse well with water.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Before applying the medication, clean the affected area and dry it thoroughly. Then, apply the medication to clean, dry, healthy skin.
Unless your doctor advises you to do so, do not cover the treated area with bandages or dressings.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Do not freeze the medication.
Store all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications responsibly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in drug take-back programs in your area.
Missed Dose Instructions
If you use this medication on a regular basis and miss a dose:
Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
* If you use this medication on an as-needed basis, do not use it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication to your skin only, as instructed by your doctor. Do not take it by mouth.
Avoid getting this medication in your mouth, nose, or eyes, as it may cause burning. If you accidentally get it in any of these areas, rinse well with water.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Before applying the medication, clean the affected area and dry it thoroughly. Then, apply the medication to clean, dry, healthy skin.
Unless your doctor advises you to do so, do not cover the treated area with bandages or dressings.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Do not freeze the medication.
Store all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications responsibly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in drug take-back programs in your area.
Missed Dose Instructions
If you use this medication on a regular basis and miss a dose:
Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
* If you use this medication on an as-needed basis, do not use it more frequently than directed by your doctor.
Lifestyle & Tips
- Use exactly as directed by your healthcare provider. Do not use more than the prescribed amount or apply to larger areas than instructed.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not swallow the jelly, especially if used in the mouth or throat, as it can numb the swallowing reflex and lead to choking or aspiration. Spit out excess if used orally.
- Wash hands thoroughly before and after applying the jelly.
- Do not apply to large areas of broken or irritated skin unless specifically instructed by a doctor, as this can increase absorption and risk of side effects.
- Keep out of reach of children and pets. Accidental ingestion can be dangerous.
Available Forms & Alternatives
Available Strengths:
- Lidocaine 4% Top Soln 50ml
- Lidocaine 2% Visc Oral Solution
- Lidocaine 1% Inj, 10ml
- Lidocaine 2% Inj, 2ml
- Lidocaine 4% Injection, 5ml
- Lidocaine 1% Inj, 5ml
- Lidocaine 1% Inj, 20ml
- Lidocaine 2% Inj, 20ml
- Lidocaine 1% Inj, 2ml
- Lidocaine 1% Inj, 50ml
- Lidocaine 2% Inj, 5ml
- Lidocaine 2% Inj, 10ml
- Lidocaine 1% Inj, 30ml
- Lidocaine 2% Inj, 50ml
- Lidocaine 2% Inj, 5ml
- Lidocaine 10mg/ml Inj, 5ml
- Lidocaine 3% Cream 28.35gm
- Lidocaine 3% Cream 85gm
- Lidocaine 2% Topical Jelly 5ml
- Lidocaine 2% Topical Jelly 10ml
- Lidocaine 2% Topical Jelly 20ml
- Lidocaine 20mg/ml Inj, 5ml
- Lidocaine 2% Jelly Gel (uro-Jet)5ml
- Lidocaine 0.5% Inj, 50ml
- Lidocaine 5% Patch
- Lidocaine 5% Topical Ointment 30gm
- Lidocaine 5% Topical Oint 35.44gm
- Lidocaine 5% Topical Ointment 50gm
- Lidocaine 1.5% Inj, 1 Ampule
- Lidocaine 5% Top/oral Oint 50gm
- Lidocaine 4% Cream 15gm
- Lidocaine 4% Cream 30gm
- Lidocaine 4% Cream 5gm
- Lidocaine 3% Cream 85gm
- Lidocaine Pain Relief 4% Patch
- Lidocaine 5% Top/oral Oint (sprmt)
- Lidocaine 5% Anorectal Cream
- Lidocaine 4% Cream 15gm
- Lidocaine 5% Topical Ointment 30gm
- Lidocaine 5% Anorectal Cream 15gm
- Lidocaine Pain Relief 4% Patch
- Lidocaine 5% Cream 30gm
- Lidocaine 2% Inj 25ml
- Lidocaine 5% Ointment 50gm
- Lidocaine 4% Cream 15gm
- Lidocaine 4% Topical Pain Patch
- Lidocaine 3%/hc 0.5% Cream 28.3gm
- Lidocaine 2% Topical Jelly 30ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply 2% jelly to the affected area as needed. Maximum recommended dose is 5 mg/kg (2.5 mL of 2% jelly per 5 kg body weight) in a single application, not to exceed 300 mg (15 mL of 2% jelly) in a 12-hour period.
Condition-Specific Dosing:
mucousMembranes:
Apply a thin layer to the mucous membrane for anesthesia. For procedures like cystoscopy, instill 6-10 mL into the urethra.
skin:
Not typically used for intact skin; primarily for mucous membranes or broken skin for local anesthesia.
Pediatric Dosing
Neonatal:
Not established. Use with extreme caution due to risk of systemic toxicity.
Infant:
Dosing should be calculated based on weight (e.g., 2.5-3 mg/kg) and not exceed 4.5 mg/kg in a single application. Max 300 mg/24 hours. Use smallest effective amount.
Child:
Dosing should be calculated based on weight (e.g., 2.5-3 mg/kg) and not exceed 4.5 mg/kg in a single application. Max 300 mg/24 hours. Use smallest effective amount.
Adolescent:
Dosing should be calculated based on weight (e.g., 2.5-3 mg/kg) and not exceed 4.5 mg/kg in a single application. Max 300 mg/24 hours. Use smallest effective amount.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical application with limited systemic absorption.
Moderate:
No specific adjustment needed for topical application with limited systemic absorption.
Severe:
Use with caution. While systemic absorption from topical jelly is low, accumulation of lidocaine or its metabolites could occur with extensive use or impaired skin barrier. Monitor for signs of toxicity.
Dialysis:
Considerations: Use with caution. Monitor for signs of toxicity if significant systemic absorption is anticipated.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical application with limited systemic absorption.
Moderate:
Use with caution. Lidocaine is primarily metabolized by the liver. Reduced metabolism could lead to higher systemic levels if significant absorption occurs. Monitor for signs of toxicity.
Severe:
Use with caution. Lidocaine is primarily metabolized by the liver. Reduced metabolism could lead to higher systemic levels if significant absorption occurs. Monitor for signs of toxicity.
Pharmacology
Mechanism of Action
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. It blocks voltage-gated sodium channels in the neuronal cell membrane, preventing depolarization and propagation of action potentials.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on site of application, duration of exposure, and integrity of skin/mucous membrane). Systemic absorption is generally low from intact skin but significantly higher from mucous membranes or abraded skin.
Tmax:
Variable, typically 10-60 minutes after topical application to mucous membranes.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
0.7-2.7 L/kg (systemic)
ProteinBinding:
60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration:
Limited (significant penetration only with systemic absorption)
Elimination:
HalfLife:
1.5-2 hours (systemic)
Clearance:
10-20 mL/min/kg (systemic)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Less than 10% (systemic)
Pharmacodynamics
OnsetOfAction:
2-5 minutes (topical to mucous membranes)
PeakEffect:
5-10 minutes (topical to mucous membranes)
DurationOfAction:
10-20 minutes (topical to mucous membranes), up to 30-60 minutes depending on site and concentration.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), including:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Respiratory problems, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
Severe numbness and tingling
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Seizures
Changes in vision
Feeling nervous and excitable
Dizziness or fainting
Ringing in the ears
Nausea or vomiting
Feeling excessively hot or cold
Shakiness
Twitching
Slow heartbeat
Chest pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you're concerned about any of the following:
Irritation at the site of application
Swelling
Redness
Changes in skin color
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), including:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Respiratory problems, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
Severe numbness and tingling
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Seizures
Changes in vision
Feeling nervous and excitable
Dizziness or fainting
Ringing in the ears
Nausea or vomiting
Feeling excessively hot or cold
Shakiness
Twitching
Slow heartbeat
Chest pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you're concerned about any of the following:
Irritation at the site of application
Swelling
Redness
Changes in skin color
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
- Signs of too much medicine absorbed (systemic toxicity): dizziness, drowsiness, confusion, ringing in ears (tinnitus), blurred vision, tremors, muscle twitching, seizures, slow heart rate, low blood pressure.
- Signs of methemoglobinemia (rare): pale, gray, or bluish skin, lips, and nail beds; shortness of breath; fatigue; rapid heart rate. Seek immediate medical attention if these occur.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
The presence of an infection at the site where the medication will be applied.
Any broken skin or open wounds at the intended application site.
Swollen skin, numbness, or loss of sensation at the application site, as these conditions may affect the medication's absorption or increase the risk of adverse reactions.
If a large area of your body needs to be treated, as this may require special consideration.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:
All your current health problems, as they may interact with this medication.
* Any potential interactions between this medication and your other medications or health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
The presence of an infection at the site where the medication will be applied.
Any broken skin or open wounds at the intended application site.
Swollen skin, numbness, or loss of sensation at the application site, as these conditions may affect the medication's absorption or increase the risk of adverse reactions.
If a large area of your body needs to be treated, as this may require special consideration.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:
All your current health problems, as they may interact with this medication.
* Any potential interactions between this medication and your other medications or health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
A rare but serious blood condition called methemoglobinemia can occur with the use of this drug. Your risk may be higher if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), heart problems, or lung problems. Additionally, the risk may increase when taking certain other medications or in infants under 6 months of age. If you have a history of methemoglobinemia, be sure to discuss this with your doctor.
Before using any other medications or skin products, including soaps, consult with your doctor. Do not use this medication for a longer period than prescribed by your doctor.
To ensure safe use, follow these guidelines:
- Avoid scratching or rubbing the skin while it is numb.
- Do not expose the treated skin to extreme temperatures.
- Unless directed by your doctor, do not apply this medication to cuts, scrapes, or damaged skin.
When using this medication, avoid heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated waterbeds. Also, avoid taking long, hot baths or sunbathing, as these can cause your body temperature to rise, leading to excessive absorption of the medication.
If this medication is swallowed, it can be harmful. In the event of ingestion, immediately contact a doctor or a poison control center.
The use of this medication in children requires careful consideration, as different brands may be suitable for different age groups. Consult with your doctor before administering this medication to a child. Children may be at a higher risk for certain side effects.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of using this medication with your doctor.
A rare but serious blood condition called methemoglobinemia can occur with the use of this drug. Your risk may be higher if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), heart problems, or lung problems. Additionally, the risk may increase when taking certain other medications or in infants under 6 months of age. If you have a history of methemoglobinemia, be sure to discuss this with your doctor.
Before using any other medications or skin products, including soaps, consult with your doctor. Do not use this medication for a longer period than prescribed by your doctor.
To ensure safe use, follow these guidelines:
- Avoid scratching or rubbing the skin while it is numb.
- Do not expose the treated skin to extreme temperatures.
- Unless directed by your doctor, do not apply this medication to cuts, scrapes, or damaged skin.
When using this medication, avoid heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated waterbeds. Also, avoid taking long, hot baths or sunbathing, as these can cause your body temperature to rise, leading to excessive absorption of the medication.
If this medication is swallowed, it can be harmful. In the event of ingestion, immediately contact a doctor or a poison control center.
The use of this medication in children requires careful consideration, as different brands may be suitable for different age groups. Consult with your doctor before administering this medication to a child. Children may be at a higher risk for certain side effects.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of using this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Severe dizziness or lightheadedness
- Numbness around the mouth or tongue
- Tingling sensations
- Ringing in the ears (tinnitus)
- Blurred or double vision
- Slurred speech
- Tremors or muscle twitching
- Seizures
- Drowsiness or loss of consciousness
- Slow or irregular heartbeat
- Low blood pressure
- Difficulty breathing
What to Do:
If you suspect an overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). In severe cases, emergency medical services may be required to manage seizures, respiratory depression, or cardiovascular collapse.
Drug Interactions
Major Interactions
- Antiarrhythmics (Class I, e.g., mexiletine, tocainide): Increased risk of cardiac depression and CNS effects if significant systemic absorption occurs.
- Other local anesthetics: Additive systemic toxicity (CNS, cardiovascular) if significant absorption occurs.
Moderate Interactions
- Beta-blockers (e.g., propranolol): May reduce hepatic blood flow, potentially decreasing lidocaine clearance and increasing systemic levels if significant absorption occurs.
- Cimetidine: May inhibit lidocaine metabolism, increasing systemic levels if significant absorption occurs.
- CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): May increase lidocaine systemic levels if significant absorption occurs.
- CYP1A2 inhibitors (e.g., fluvoxamine): May increase lidocaine systemic levels if significant absorption occurs.
Monitoring
Routine Monitoring
Signs and symptoms of systemic toxicity (CNS, cardiovascular)
Frequency: During and immediately after application, especially with large areas, prolonged use, or compromised skin/mucosa.
Target: Absence of symptoms
Action Threshold: Any signs of dizziness, drowsiness, confusion, tremors, seizures, bradycardia, hypotension, or cardiac arrest require immediate medical attention.
Symptom Monitoring
- Local irritation (redness, swelling, itching, burning)
- Allergic reactions (rash, hives, swelling, difficulty breathing)
- CNS toxicity (dizziness, lightheadedness, drowsiness, confusion, disorientation, tinnitus, blurred vision, tremors, muscle twitching, seizures, slurred speech)
- Cardiovascular toxicity (bradycardia, hypotension, cardiac arrest)
- Methemoglobinemia (rare, but possible with high doses or prolonged use, especially in infants: cyanosis, shortness of breath, fatigue, rapid heart rate)
Special Patient Groups
Pregnancy
Lidocaine is considered Category B for topical use. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Systemic absorption from topical application is generally low, minimizing fetal exposure.
Trimester-Specific Risks:
First Trimester:
Low risk based on limited systemic absorption.
Second Trimester:
Low risk based on limited systemic absorption.
Third Trimester:
Low risk based on limited systemic absorption.
Lactation
Lidocaine is excreted into breast milk in small amounts. However, due to its low oral bioavailability and rapid metabolism, the amount transferred to the infant is generally considered clinically insignificant. It is rated L2 (likely compatible with breastfeeding).
Infant Risk:
Low risk. Monitor infant for unusual drowsiness or feeding difficulties, though unlikely with typical topical use.
Pediatric Use
Use with extreme caution, especially in infants and young children, due to their higher surface area to body weight ratio, which can lead to increased systemic absorption and a higher risk of systemic toxicity (e.g., seizures, methemoglobinemia). Dosing must be carefully calculated based on weight and not exceed recommended maximums. Avoid use on large areas or broken skin.
Geriatric Use
No specific dose adjustment is typically needed for topical lidocaine jelly. However, elderly patients may be more susceptible to systemic adverse effects if significant absorption occurs due to potential age-related decreases in hepatic function, cardiac output, and renal function. Use the lowest effective dose and monitor for signs of toxicity.
Clinical Information
Clinical Pearls
- Lidocaine jelly is primarily used for local anesthesia of mucous membranes (e.g., oral, pharyngeal, urethral, rectal) or for lubrication of instruments.
- The 2% concentration is suitable for most mucous membrane applications. Higher concentrations (e.g., 5% patches) are typically for intact skin.
- Instruct patients not to swallow the jelly, especially when used in the mouth/throat, as it can numb the gag reflex and lead to aspiration.
- Be vigilant for signs of systemic toxicity (CNS and cardiovascular) if applied to large areas, broken skin, or used for prolonged periods, particularly in children or patients with liver impairment.
- Methemoglobinemia is a rare but serious side effect, especially in infants, and should be considered if cyanosis unresponsive to oxygen occurs.
Alternative Therapies
- Other local anesthetics (e.g., bupivacaine, ropivacaine - typically injectable)
- Topical analgesics (e.g., diclofenac gel, capsaicin cream - different mechanisms)
- Oral analgesics (e.g., NSAIDs, acetaminophen)
- Cryotherapy (ice packs)
Cost & Coverage
Average Cost:
$5 - $20 per 5ml tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.