Analgesic Balm Cream 85gm
It is used to ease muscle and joint aches and pain.
Drug Class
Topical Analgesic, Counterirritant
Pharmacologic Class
Salicylate (Methyl Salicylate), Monoterpene Alcohol (Menthol)
Pregnancy Category
Category C (Methyl Salicylate, especially in 3rd trimester, may be D)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This cream is used on the skin to relieve minor aches and pains of muscles and joints. It works by creating a cooling and then warming sensation that distracts from the pain.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Before and after applying the medication, wash your hands thoroughly, unless the treated area is on your hand. In that case, do not wash your hand after application. Apply a thin layer of the medication to the clean, dry, and healthy skin, gently rubbing it in. Ensure the skin is free of irritation or damage before application. It's also important to wait until the skin is completely dry after a shower or bath before applying the medication. Avoid covering the treated area with a tight bandage.
To minimize potential side effects, avoid exposing the treated area to direct sunlight. If you have any questions or concerns about using this medication, consult your doctor or pharmacist.
Storing and Disposing of Your Medication
Store this medication at room temperature, keeping it out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the proper disposal method or participate in a local drug take-back program if available.
Managing Missed Doses
If you use this medication on a regular schedule and miss a dose, apply it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular application schedule. Do not apply extra doses or double doses to make up for a missed dose. If you use this medication as needed, follow your doctor's instructions for frequency of application and do not use it more often than recommended.
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Before and after applying the medication, wash your hands thoroughly, unless the treated area is on your hand. In that case, do not wash your hand after application. Apply a thin layer of the medication to the clean, dry, and healthy skin, gently rubbing it in. Ensure the skin is free of irritation or damage before application. It's also important to wait until the skin is completely dry after a shower or bath before applying the medication. Avoid covering the treated area with a tight bandage.
To minimize potential side effects, avoid exposing the treated area to direct sunlight. If you have any questions or concerns about using this medication, consult your doctor or pharmacist.
Storing and Disposing of Your Medication
Store this medication at room temperature, keeping it out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the proper disposal method or participate in a local drug take-back program if available.
Managing Missed Doses
If you use this medication on a regular schedule and miss a dose, apply it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular application schedule. Do not apply extra doses or double doses to make up for a missed dose. If you use this medication as needed, follow your doctor's instructions for frequency of application and do not use it more often than recommended.
Lifestyle & Tips
- For external use only. Do not ingest.
- Avoid contact with eyes, mucous membranes, and broken or irritated skin.
- Do not apply to wounds or damaged skin.
- Do not bandage tightly or use with a heating pad.
- Wash hands thoroughly after applying the cream.
- Keep out of reach of children and pets.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area not more than 3 to 4 times daily.
Condition-Specific Dosing:
pain:
Apply a thin layer to the affected area and gently massage until absorbed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Consult a doctor for children under 12 years of age.
Adolescent:
Apply to affected area not more than 3 to 4 times daily (for ages 12 and older).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Methyl Salicylate acts as a counterirritant, producing a sensation of warmth that distracts from deeper pain. It also has mild analgesic properties by inhibiting prostaglandin synthesis if absorbed systemically. Menthol acts as a counterirritant by activating TRPM8 receptors, producing a cooling sensation followed by a warming effect, and may also have mild local anesthetic properties.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic bioavailability via topical application; varies based on skin integrity, application area, and duration.
Tmax:
Not well-defined for topical application; counterirritant effect is rapid (minutes). Systemic absorption of methyl salicylate can peak within hours if significant.
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable for topical use with minimal systemic absorption.
ProteinBinding:
Salicylates are highly protein bound (90% or more) if absorbed systemically.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Salicylic acid: 2-4.5 hours (low dose), 15-30 hours (high dose); Menthol: ~2-4 hours.
Clearance:
Primarily renal for salicylic acid.
ExcretionRoute:
Renal (as salicylic acid and its metabolites; menthol metabolites)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within minutes (for counterirritant effect)
PeakEffect:
Within 15-30 minutes (for counterirritant effect)
DurationOfAction:
2-4 hours
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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
Skin irritation
Redness
Severe stomach pain
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
Severe dizziness or fainting
Chest pain or pressure
Weakness on one side of the body
Trouble speaking or thinking
Change in balance
Drooping on one side of the face
Blurred vision
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 discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Burning
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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
Skin irritation
Redness
Severe stomach pain
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
Severe dizziness or fainting
Chest pain or pressure
Weakness on one side of the body
Trouble speaking or thinking
Change in balance
Drooping on one side of the face
Blurred vision
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 discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Burning
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact 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:
- Severe skin irritation, redness, rash, or blistering at the application site.
- Worsening of pain or condition after 7 days of use.
- Symptoms of allergic reaction (e.g., difficulty breathing, swelling of face/throat, severe rash).
- Symptoms of salicylate toxicity (rare with topical use, but possible with excessive use): ringing in ears, dizziness, nausea, vomiting.
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 allergic reaction you experienced.
If you have an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If you are currently taking any other NSAID.
If you are taking a salicylate drug, such as aspirin.
* If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This medication may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.
Additionally, it is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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 allergic reaction you experienced.
If you have an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If you are currently taking any other NSAID.
If you are taking a salicylate drug, such as aspirin.
* If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This medication may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.
Additionally, it is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When using this medication, avoid applying heat to the treated area using a heating pad or other heating devices. If you are currently taking aspirin to prevent a heart attack, consult with your doctor to discuss potential interactions.
This medication may increase the risk of serious cardiovascular problems, including heart attack and stroke, which can be fatal. This risk may be higher if you have pre-existing heart disease or factors that increase your risk of developing heart disease. However, it is crucial to note that this risk can occur even in individuals without a history of heart disease or risk factors. The risk of cardiovascular problems can arise within the first few weeks of treatment and may be greater with higher doses or prolonged use. Therefore, do not use this medication immediately before or after undergoing bypass heart surgery.
Additionally, this medication may increase the risk of severe and potentially life-threatening stomach or bowel problems, such as ulcers or bleeding. This risk is higher in older adults and individuals who have a history of stomach or bowel ulcers or bleeding. These problems can occur without warning signs, making it essential to be aware of the potential risks.
Before consuming alcohol, consult with your doctor to discuss potential interactions. When applying this medication to a large area of skin, exercise caution and consult with your doctor.
If this medication is accidentally ingested, seek immediate medical attention by calling a doctor or poison control center. This medication should not be given to children under 12 years old without first consulting with a doctor.
If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects. If you are breast-feeding, inform your doctor, as you will need to discuss potential risks to your baby.
When using this medication, avoid applying heat to the treated area using a heating pad or other heating devices. If you are currently taking aspirin to prevent a heart attack, consult with your doctor to discuss potential interactions.
This medication may increase the risk of serious cardiovascular problems, including heart attack and stroke, which can be fatal. This risk may be higher if you have pre-existing heart disease or factors that increase your risk of developing heart disease. However, it is crucial to note that this risk can occur even in individuals without a history of heart disease or risk factors. The risk of cardiovascular problems can arise within the first few weeks of treatment and may be greater with higher doses or prolonged use. Therefore, do not use this medication immediately before or after undergoing bypass heart surgery.
Additionally, this medication may increase the risk of severe and potentially life-threatening stomach or bowel problems, such as ulcers or bleeding. This risk is higher in older adults and individuals who have a history of stomach or bowel ulcers or bleeding. These problems can occur without warning signs, making it essential to be aware of the potential risks.
Before consuming alcohol, consult with your doctor to discuss potential interactions. When applying this medication to a large area of skin, exercise caution and consult with your doctor.
If this medication is accidentally ingested, seek immediate medical attention by calling a doctor or poison control center. This medication should not be given to children under 12 years old without first consulting with a doctor.
If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects. If you are breast-feeding, inform your doctor, as you will need to discuss potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose: Severe skin irritation, burning, blistering.
- Systemic overdose (rare, usually from ingestion or excessive topical use): Nausea, vomiting, abdominal pain, ringing in ears (tinnitus), dizziness, confusion, rapid breathing, fever, seizures, coma.
What to Do:
For topical overdose, wash the area thoroughly with soap and water. For suspected systemic overdose or accidental ingestion, seek immediate medical attention. Call 911 or a Poison Control Center (1-800-222-1222).
Drug Interactions
Major Interactions
- Anticoagulants (e.g., Warfarin): Theoretical risk of increased bleeding due to salicylate absorption, especially with large application areas or prolonged use.
Moderate Interactions
- Other NSAIDs/Salicylates: Additive systemic effects if significant absorption occurs, increasing risk of salicylate toxicity.
- Methotrexate: Theoretical risk of increased methotrexate levels due to salicylate displacement from protein binding or reduced renal clearance.
Monitoring
Symptom Monitoring
- Effectiveness of pain relief
- Skin irritation (redness, rash, itching, burning)
- Signs of allergic reaction (swelling, blistering)
- Worsening of pain or condition
Special Patient Groups
Pregnancy
Use with caution during pregnancy, especially in the third trimester. Methyl salicylate is a salicylate, and systemic absorption, though low, could theoretically pose risks similar to oral salicylates (e.g., premature closure of ductus arteriosus, prolonged labor, increased bleeding risk). Consult a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk, but consult physician.
Second Trimester:
Generally considered low risk, but consult physician.
Third Trimester:
Avoid or use with extreme caution due to potential for premature closure of ductus arteriosus and increased bleeding risk in mother and fetus.
Lactation
Use with caution. Salicylates can be excreted in breast milk. While systemic absorption from topical application is low, the potential for infant exposure exists. Consult a healthcare provider before use.
Infant Risk:
Low to moderate risk. Monitor infant for adverse effects if used.
Pediatric Use
Not recommended for children under 12 years of age without consulting a doctor due to theoretical concerns of Reye's syndrome with salicylate exposure, although the risk from topical application is very low. Keep out of reach of children.
Geriatric Use
Generally safe for use in the elderly. However, older adults may have more sensitive skin and should be monitored for skin irritation or allergic reactions. Use the lowest effective amount.
Clinical Information
Clinical Pearls
- This product is for external use only. Emphasize not to ingest or apply to open wounds, damaged skin, or mucous membranes.
- Advise patients to wash their hands thoroughly after applying the cream to avoid accidental exposure to eyes or other sensitive areas.
- Warn against using heating pads or tight bandages over the applied area, as this can increase absorption and risk of skin irritation or systemic effects.
- Patients should discontinue use and consult a doctor if pain worsens, persists for more than 7 days, or if skin irritation/rash develops.
- While systemic absorption is generally low, caution should be exercised in patients on anticoagulants due to the salicylate component.
Alternative Therapies
- Topical NSAID gels (e.g., diclofenac gel)
- Topical capsaicin cream
- Topical lidocaine patches/creams
- Oral analgesics (e.g., acetaminophen, ibuprofen)
- Heat or cold therapy
- Physical therapy
Cost & Coverage
Average Cost:
$5 - $15 per 85gm tube
Generic Available:
Yes
Insurance Coverage:
Not typically covered by insurance (OTC product)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It is also important to note that some medications may have additional patient information leaflets, so be sure to consult with your pharmacist if you have any questions. If you are unsure about any aspect of your medication, including its use, potential side effects, or interactions, do not hesitate to discuss your concerns 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 name of the medication taken, the amount, and the time it occurred.