Keralyt 6% Gel 100gm (rx)
It is used to get rid of calluses, corns, and warts.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Keratolytic Agent
Pharmacologic Class
Salicylic Acid Derivative
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Salicylic acid gel is a medicine applied to the skin to help soften and remove hardened skin, such as calluses, corns, or warts. It works by helping the outer layer of skin to shed more easily.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication directly to the affected skin area only. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
If the medication accidentally gets into your eyes, rinse them with cool water immediately.
Before applying the medication, clean the affected area thoroughly and dry it well.
Avoid inhaling the vapors emitted by the medication.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
You may soak the affected area in water for 5 minutes before applying the medication, if desired.
If your doctor advises you to do so, you may cover the treated area with a thin dressing after application.
Apply the medication to the affected skin area and allow it to dry completely.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Protect the medication from heat sources and open flames.
Keep the container lid tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication directly to the affected skin area only. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
If the medication accidentally gets into your eyes, rinse them with cool water immediately.
Before applying the medication, clean the affected area thoroughly and dry it well.
Avoid inhaling the vapors emitted by the medication.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
You may soak the affected area in water for 5 minutes before applying the medication, if desired.
If your doctor advises you to do so, you may cover the treated area with a thin dressing after application.
Apply the medication to the affected skin area and allow it to dry completely.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Protect the medication from heat sources and open flames.
Keep the container lid tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash and dry the affected area thoroughly before applying the gel.
- Apply a thin layer of gel only to the affected skin, avoiding contact with healthy skin, eyes, nose, mouth, or other mucous membranes.
- Wash hands immediately after applying the gel.
- Do not use on irritated, inflamed, broken, or infected skin.
- Avoid using on large areas of the body or for prolonged periods without medical supervision, as this can increase the risk of side effects.
- Keep the treated area clean and dry.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area once or twice daily, or as directed by physician.
Condition-Specific Dosing:
calluses_corns_warts:
Apply a thin layer to the affected area, typically once or twice daily. May be covered with an occlusive dressing if directed by physician. Treatment duration varies based on condition and response.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Use with caution; avoid large surface areas or prolonged use due to risk of systemic absorption and salicylism. Consult physician.
Adolescent:
Use with caution; avoid large surface areas or prolonged use due to risk of systemic absorption and salicylism. Consult physician.
Dose Adjustments
Renal Impairment:
Mild:
Not typically required for topical use with limited absorption.
Moderate:
Not typically required for topical use with limited absorption. Use with caution if large areas are treated or skin is compromised.
Severe:
Use with caution; avoid large surface areas or prolonged use due to potential for systemic absorption and accumulation of salicylates. Monitor for signs of salicylism.
Dialysis:
Not typically required for topical use. Avoid large surface areas or prolonged use.
Hepatic Impairment:
Mild:
Not typically required for topical use with limited absorption.
Moderate:
Not typically required for topical use with limited absorption. Use with caution if large areas are treated or skin is compromised.
Severe:
Use with caution; avoid large surface areas or prolonged use due to potential for systemic absorption and impaired metabolism. Monitor for signs of salicylism.
Pharmacology
Mechanism of Action
Salicylic acid is a keratolytic agent. It works by softening and dissolving the intercellular cement in the stratum corneum, causing the cornified epithelium to swell, soften, and desquamate. It also has mild antiseptic and antifungal properties.
Pharmacokinetics
Absorption:
Bioavailability:
Limited systemic absorption from topical application, but can increase with large surface areas, prolonged use, occlusive dressings, or compromised skin integrity.
Tmax:
Not well-defined for topical application; systemic absorption is slow.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application; systemically absorbed salicylic acid distributes widely.
ProteinBinding:
Highly protein bound (to albumin) when systemically absorbed.
CnssPenetration:
Limited for topical application; can penetrate CNS if significant systemic absorption occurs (e.g., in salicylism).
Elimination:
HalfLife:
Approximately 2-3 hours for low doses; can be dose-dependent and prolonged with higher systemic concentrations.
Clearance:
Primarily renal excretion.
ExcretionRoute:
Renal (urine)
Unchanged:
Small percentage excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Keratolytic effect typically observed within days of consistent application.
PeakEffect:
Full therapeutic effect may take several weeks of continuous use.
DurationOfAction:
Effect persists as long as treatment is continued.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when 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
Mood changes
Fast breathing
Upset stomach or vomiting
Ringing in the ears, hearing loss, or other changes in hearing
Dizziness
Feeling very tired or weak
Diarrhea
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 symptoms that bother you or do not go away, contact your doctor:
Skin irritation
Dry skin
Burning or stinging
Peeling
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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
Mood changes
Fast breathing
Upset stomach or vomiting
Ringing in the ears, hearing loss, or other changes in hearing
Dizziness
Feeling very tired or weak
Diarrhea
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 symptoms that bother you or do not go away, contact your doctor:
Skin irritation
Dry skin
Burning or stinging
Peeling
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. 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 burning, stinging, itching, or redness at the application site.
- Signs of skin infection (e.g., pus, increased pain, swelling, warmth).
- Signs of systemic toxicity (salicylism): ringing in the ears, dizziness, headache, nausea, vomiting, confusion, or very rapid breathing. 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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ High blood sugar (diabetes)
+ Poor blood flow
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all 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, including any symptoms that occurred.
Certain health conditions, including:
+ High blood sugar (diabetes)
+ Poor blood flow
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all 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 certain acne products that contain benzoyl peroxide or salicylic acid, there is a rare risk of severe and potentially life-threatening allergic reactions or irritation. To minimize this risk, you may need to follow specific steps before using the product for the first time. Be sure to use this medication exactly as directed by your doctor or as instructed on the package label. If you have any questions or concerns, consult with your doctor.
To ensure safe use, avoid applying this medication to open wounds, cuts, or irritated skin. When using it on a large area of skin, exercise caution and discuss any concerns with your doctor. Additionally, do not use this medication on birthmarks, moles, or warts with hair growth, or on cervical, genital, or oral warts.
Using this medication too frequently can worsen your skin condition. Furthermore, using other skin products in conjunction with this medication may increase the risk of irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor.
It is crucial to inform your doctor and laboratory personnel that you are using this medication, as it may affect certain lab test results. Some of these medications are flammable, so avoid using them near an open flame or while smoking. If ingested, this medication can cause harm, so if you or someone else swallows it, contact a doctor or poison control center immediately.
This medication is not recommended for children and teenagers who have or are recovering from flu symptoms, chickenpox, or other viral infections, due to the risk of Reye's syndrome, a condition that can cause severe brain and liver damage. If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. Different brands of this medication may be suitable for different age groups, so consult with your doctor before administering it to a child.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of using this medication with your doctor. If you are breastfeeding, avoid applying this medication to your chest, and consult with your doctor for guidance.
When using certain acne products that contain benzoyl peroxide or salicylic acid, there is a rare risk of severe and potentially life-threatening allergic reactions or irritation. To minimize this risk, you may need to follow specific steps before using the product for the first time. Be sure to use this medication exactly as directed by your doctor or as instructed on the package label. If you have any questions or concerns, consult with your doctor.
To ensure safe use, avoid applying this medication to open wounds, cuts, or irritated skin. When using it on a large area of skin, exercise caution and discuss any concerns with your doctor. Additionally, do not use this medication on birthmarks, moles, or warts with hair growth, or on cervical, genital, or oral warts.
Using this medication too frequently can worsen your skin condition. Furthermore, using other skin products in conjunction with this medication may increase the risk of irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor.
It is crucial to inform your doctor and laboratory personnel that you are using this medication, as it may affect certain lab test results. Some of these medications are flammable, so avoid using them near an open flame or while smoking. If ingested, this medication can cause harm, so if you or someone else swallows it, contact a doctor or poison control center immediately.
This medication is not recommended for children and teenagers who have or are recovering from flu symptoms, chickenpox, or other viral infections, due to the risk of Reye's syndrome, a condition that can cause severe brain and liver damage. If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. Different brands of this medication may be suitable for different age groups, so consult with your doctor before administering it to a child.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of using this medication with your doctor. If you are breastfeeding, avoid applying this medication to your chest, and consult with your doctor for guidance.
Overdose Information
Overdose Symptoms:
- Tinnitus (ringing in the ears)
- Dizziness
- Headache
- Nausea
- Vomiting
- Hyperventilation (rapid breathing)
- Confusion
- Lethargy
- Diarrhea
What to Do:
If you suspect an overdose, discontinue use immediately and contact a poison control center (Call 1-800-222-1222) or seek emergency medical attention. Treatment is supportive and may involve activated charcoal, gastric lavage, or hemodialysis in severe cases.
Drug Interactions
Moderate Interactions
- Other topical irritants or peeling agents (e.g., retinoids, benzoyl peroxide, other keratolytics): Increased risk of severe local irritation or dermatitis.
- Topical corticosteroids: May alter absorption or efficacy, use with caution.
Monitoring
Baseline Monitoring
Skin assessment of affected area
Rationale: To establish baseline condition, identify any pre-existing irritation, open wounds, or infections.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin reaction (redness, irritation, peeling, discomfort)
Frequency: Daily or with each application
Target: Minimal to mild irritation is expected; severe irritation is not.
Action Threshold: Discontinue use if excessive irritation, pain, or signs of infection occur. Consult physician.
Therapeutic response (softening/reduction of lesion)
Frequency: Weekly
Target: Gradual improvement in skin texture and lesion size.
Action Threshold: Re-evaluate treatment if no improvement after several weeks or if condition worsens.
Signs of systemic salicylism (tinnitus, dizziness, headache, nausea, vomiting, hyperventilation)
Frequency: Periodically, especially with large surface area application or prolonged use
Target: Absence of symptoms.
Action Threshold: Discontinue use immediately and seek medical attention if any signs of systemic toxicity appear.
Symptom Monitoring
- Excessive skin irritation, redness, burning, itching, or pain at application site.
- Signs of infection (pus, increased warmth, swelling).
- Systemic symptoms: ringing in ears (tinnitus), dizziness, headache, confusion, rapid breathing, nausea, vomiting, unusual fatigue.
Special Patient Groups
Pregnancy
Category C. Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Avoid use on large surface areas or for prolonged periods due to potential for systemic absorption and fetal exposure.
Trimester-Specific Risks:
First Trimester:
Potential risk, avoid if possible.
Second Trimester:
Potential risk, avoid if possible.
Third Trimester:
Potential risk, especially near term, due to theoretical risk of premature closure of ductus arteriosus (similar to oral salicylates). Avoid.
Lactation
L3 (Moderate risk). Salicylic acid is excreted in breast milk. While systemic absorption from topical application is generally low, caution is advised. Avoid applying to areas that may come into direct contact with the infant's skin or mouth. Use on small areas for limited duration.
Infant Risk:
Potential for infant exposure via breast milk or direct skin contact. Monitor for signs of salicylate toxicity in the infant (e.g., lethargy, poor feeding).
Pediatric Use
Use with extreme caution in children, especially infants and young children, due to increased risk of systemic absorption and salicylism. Avoid use on large surface areas, broken skin, or under occlusive dressings. Consult a physician for appropriate use and concentration.
Geriatric Use
No specific dose adjustments are typically required. However, elderly patients may have thinner or more fragile skin, increasing susceptibility to irritation or absorption. Monitor skin integrity and local reactions closely.
Clinical Information
Clinical Pearls
- Salicylic acid is a potent keratolytic; apply only to the affected area to avoid irritation or damage to surrounding healthy skin.
- For warts, corns, and calluses, consistent daily application is key for efficacy. Treatment may take several weeks.
- Avoid contact with eyes, mucous membranes, and open wounds.
- If excessive irritation occurs, reduce frequency of application or temporarily discontinue use.
- Systemic absorption, though rare with proper topical use, can lead to salicylism, especially in children or with extensive application. Be vigilant for symptoms like tinnitus or dizziness.
Alternative Therapies
- Cryotherapy (liquid nitrogen)
- Laser therapy
- Surgical excision (for warts, corns, calluses)
- Duct tape occlusion (for warts)
- Other keratolytic agents (e.g., urea, lactic acid, trichloroacetic acid)
- Imiquimod (for certain warts)
- Cantharidin (for warts)
Cost & Coverage
Average Cost:
$50 - $150 per 100gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 for prescription formulations; OTC formulations generally not covered by insurance.
General Drug Facts
If your symptoms or health issues persist or worsen, 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. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 name of the medication taken, the amount, and the time it occurred.