Keralyt 3% Gel 28.4gm
It is used to treat psoriasis.It is used to control seborrheic dermatitis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Keratolytic; Antipsoriatic; Antiseborrheic
Pharmacologic Class
Salicylic acid derivative
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Keralyt 3% Gel contains salicylic acid, which is a medicine that helps to soften and loosen thick, scaly skin. It works by helping the outer layer of skin to shed, making it useful for conditions like psoriasis and seborrheic dermatitis where there's a buildup of skin cells.
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. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. If accidental exposure occurs, rinse your eyes with cool water.
Before applying the medication, make sure to clean the affected area and dry it thoroughly. Do not inhale the vapors, and wash your hands before and after use. However, if the treated area is on your hand, do not wash that hand after application.
Apply a thin layer of the medication to the affected skin and gently rub it in. If you are using this product on your scalp, follow the specific instructions provided or consult the package insert for guidance.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures. Protect it from heat sources and open flames, and keep the lid tightly closed.
Missed Dose
If you forget to apply a dose, do so 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 one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. If accidental exposure occurs, rinse your eyes with cool water.
Before applying the medication, make sure to clean the affected area and dry it thoroughly. Do not inhale the vapors, and wash your hands before and after use. However, if the treated area is on your hand, do not wash that hand after application.
Apply a thin layer of the medication to the affected skin and gently rub it in. If you are using this product on your scalp, follow the specific instructions provided or consult the package insert for guidance.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures. Protect it from heat sources and open flames, and keep the lid tightly closed.
Missed Dose
If you forget to apply a dose, do so 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 one.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the gel.
- Apply only to the affected skin areas as directed by your doctor or pharmacist.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to open wounds, broken, or irritated skin.
- Avoid using on large areas of the body, especially in children, as this can increase the risk of systemic absorption.
- Protect treated areas from excessive sun exposure, as salicylic acid can increase sun sensitivity.
- Do not use with other topical products that may cause irritation (e.g., abrasive soaps, alcohol-containing products) unless directed by a healthcare professional.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area 1 to 2 times daily
Condition-Specific Dosing:
psoriasis:
Apply a thin layer to affected areas once or twice daily, or as directed by physician. May be used with occlusion for enhanced effect, but increases systemic absorption risk.
seborrheic_dermatitis:
Apply a thin layer to affected areas once or twice daily, or as directed by physician.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with extreme caution due to increased systemic absorption risk)
Child:
Not established (use with caution, generally not recommended for extensive areas or prolonged use due to systemic absorption risk)
Adolescent:
Apply to affected area 1 to 2 times daily, with caution regarding extensive use or prolonged duration.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical use
Moderate:
No adjustment needed for topical use
Severe:
No adjustment needed for topical use; however, caution with extensive use due to potential for systemic absorption and salicylate accumulation.
Dialysis:
Considerations: Avoid extensive use due to potential for systemic absorption and salicylate accumulation.
Hepatic Impairment:
Mild:
No adjustment needed for topical use
Moderate:
No adjustment needed for topical use
Severe:
No adjustment needed for topical use; however, caution with extensive use due to potential for systemic absorption and impaired metabolism.
Confidence:
Medium
Pharmacology
Mechanism of Action
Salicylic acid is a keratolytic agent that causes desquamation of the stratum corneum by solubilizing the intercellular cement that binds scales. It also has mild antiseptic and antifungal properties. It softens and loosens scales, making them easier to remove.
Pharmacokinetics
Absorption:
Bioavailability:
Limited systemic absorption from intact skin; increased with damaged skin, inflammation, or occlusive dressings.
Tmax:
Not applicable for topical effect; systemic absorption peak is variable (hours) if significant absorption occurs.
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable for topical use; if absorbed, distributes widely.
ProteinBinding:
Highly protein bound (primarily to albumin) if systemically absorbed.
CnssPenetration:
Limited (if systemically absorbed, can cross BBB at high concentrations)
Elimination:
HalfLife:
2-3 hours (systemic, if absorbed); can be prolonged with high doses.
Clearance:
Not applicable for topical use; renal excretion if systemically absorbed.
ExcretionRoute:
Renal (as metabolites and unchanged drug)
Unchanged:
<10% (if systemically absorbed)
Pharmacodynamics
OnsetOfAction:
Days to weeks for full keratolytic effect
PeakEffect:
Variable, depends on skin condition and duration of use.
DurationOfAction:
Variable, depends on skin turnover rate.
Confidence:
Medium
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
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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
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.
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
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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
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 skin irritation, redness, burning, or peeling that does not subside.
- Signs of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
- Signs of systemic salicylate toxicity (rare but serious): ringing in the ears (tinnitus), dizziness, headache, nausea, vomiting, rapid breathing, confusion. 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to discuss all your medications and health conditions with your doctor.
* Any health problems you have, as they may interact with this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to help you make informed decisions about your treatment.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to discuss all your medications and health conditions with your doctor.
* Any health problems you have, as they may interact with this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to help you make informed decisions about your treatment.
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. Always use this medication as directed by your doctor or as indicated on the package label, and consult with your doctor if you have any questions.
Avoid applying this medication to open wounds, cuts, or irritated skin. When using it on a large area of skin, exercise caution and discuss this with your doctor. 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. Additionally, 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.
This medication may interfere with certain laboratory tests, so it is crucial to inform your doctor and laboratory personnel that you are using it. Some formulations of this medication may be flammable, so avoid using them near open flames 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.
Do not administer this medication to children or teenagers who have or are recovering from flu symptoms, chickenpox, or other viral infections, as this may increase 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 approved for use in children of varying ages, so consult with your doctor before giving 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. Always use this medication as directed by your doctor or as indicated on the package label, and consult with your doctor if you have any questions.
Avoid applying this medication to open wounds, cuts, or irritated skin. When using it on a large area of skin, exercise caution and discuss this with your doctor. 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. Additionally, 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.
This medication may interfere with certain laboratory tests, so it is crucial to inform your doctor and laboratory personnel that you are using it. Some formulations of this medication may be flammable, so avoid using them near open flames 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.
Do not administer this medication to children or teenagers who have or are recovering from flu symptoms, chickenpox, or other viral infections, as this may increase 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 approved for use in children of varying ages, so consult with your doctor before giving 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 (especially if the product was ingested or applied extensively to large areas of skin), seek immediate medical attention or call a poison control center. For the U.S., call 1-800-222-1222. Management typically involves supportive care, correction of fluid and electrolyte imbalances, and potentially activated charcoal or hemodialysis in severe cases of systemic toxicity.
Drug Interactions
Moderate Interactions
- Topical corticosteroids (may increase absorption of corticosteroids)
- Other topical medications (may increase absorption or irritation)
Monitoring
Routine Monitoring
Skin irritation (redness, burning, peeling)
Frequency: Daily during initial use, then as needed
Target: Minimal to no irritation
Action Threshold: Discontinue use if severe irritation occurs; reduce frequency or concentration if mild to moderate irritation persists.
Therapeutic response (reduction in scaling, plaques)
Frequency: Weekly to bi-weekly
Target: Improvement in skin condition
Action Threshold: Re-evaluate treatment if no improvement after 4-6 weeks.
Symptom Monitoring
- Skin irritation (redness, burning, itching, excessive peeling)
- Signs of systemic salicylate toxicity (rare with topical use): tinnitus, dizziness, nausea, vomiting, hyperventilation, confusion (especially in children or with extensive use).
Special Patient Groups
Pregnancy
Use with caution during pregnancy. While systemic absorption from topical application is generally limited, extensive use, prolonged use, or application to large body surface areas or broken skin may lead to significant systemic absorption. High systemic levels of salicylates are associated with risks in pregnancy (e.g., prolonged gestation, increased bleeding risk, premature closure of ductus arteriosus). Consult a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk with limited topical use.
Second Trimester:
Generally considered low risk with limited topical use.
Third Trimester:
Avoid extensive use, especially late in the third trimester, due to potential for premature closure of the ductus arteriosus and inhibition of labor.
Lactation
Use with caution during lactation. Salicylic acid is excreted in breast milk if systemically absorbed. While topical absorption is limited, avoid applying to areas where the infant may come into direct contact with the medication (e.g., breasts, hands). Monitor infant for adverse effects. Consult a healthcare provider.
Infant Risk:
Low risk with limited topical use; potential for adverse effects (e.g., rash, salicylate toxicity) if significant exposure occurs.
Pediatric Use
Use with extreme caution in infants and young children due to their higher surface area to body weight ratio, which increases the risk of systemic absorption and salicylate toxicity. Not recommended for use in children under 2 years of age. For older children, use on limited areas and for short durations only, under medical supervision.
Geriatric Use
Generally safe for use in the elderly. No specific dose adjustments are typically needed. However, caution should be exercised if there is significant renal or hepatic impairment, or if extensive areas of skin are treated, due to potential for increased systemic absorption and reduced clearance.
Clinical Information
Clinical Pearls
- Salicylic acid is a cornerstone for treating hyperkeratotic skin conditions due to its excellent keratolytic properties.
- Advise patients that initial mild stinging or irritation is common but should subside. If severe, discontinue use.
- Occlusion (e.g., under bandages) can significantly enhance penetration and efficacy, but also increases the risk of systemic absorption and local irritation.
- Warn patients about potential sun sensitivity in treated areas.
- Emphasize avoiding contact with eyes and mucous membranes, as it can be highly irritating.
- For scalp conditions, apply to dry hair and scalp, leave on for a few hours or overnight, then shampoo out.
Alternative Therapies
- Urea (topical)
- Lactic acid (topical)
- Alpha hydroxy acids (AHAs)
- Topical corticosteroids (for inflammation in psoriasis/seborrheic dermatitis)
- Calcipotriene (for psoriasis)
- Tazarotene (for psoriasis)
- Antifungal agents (for seborrheic dermatitis if fungal component is significant)
- Coal tar (topical)
Cost & Coverage
Average Cost:
$30 - $70 per 28.4gm tube
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance, may be Tier 2 or 3 for brand-name products. Generic salicylic acid is usually Tier 1 or OTC.
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 for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.