Retin-A 0.01% Gel 15gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent; Keratolytic
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
May 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a form of Vitamin A that helps your skin renew itself. When applied to the skin, it helps to clear up acne by preventing clogged pores and promoting the shedding of old skin cells. It can also improve the appearance of fine wrinkles and rough skin by encouraging new, healthier skin cell growth.
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 as directed.
Application Instructions
Apply this medication only to your skin, as directed 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 accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime.
Before and after use, wash your hands thoroughly.
Gently wash the affected skin with a mild, non-medicated soap and pat it dry. You may need to wait 20 to 30 minutes after washing before applying the medication. Consult with your pharmacist for specific guidance on using this medication.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Safety Precautions
This medication is flammable, so avoid using it near an open flame or while smoking.
Storage and Disposal
Store all products at room temperature, avoiding freezing.
Missed Dose Instructions
* If you miss a dose, skip it and resume your normal application schedule. Do not apply two doses at the same time or use extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed 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 accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime.
Before and after use, wash your hands thoroughly.
Gently wash the affected skin with a mild, non-medicated soap and pat it dry. You may need to wait 20 to 30 minutes after washing before applying the medication. Consult with your pharmacist for specific guidance on using this medication.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Safety Precautions
This medication is flammable, so avoid using it near an open flame or while smoking.
Storage and Disposal
Store all products at room temperature, avoiding freezing.
Missed Dose Instructions
* If you miss a dose, skip it and resume your normal application schedule. Do not apply two doses at the same time or use extra doses to make up for the missed one.
Lifestyle & Tips
- Apply only a pea-sized amount to the entire affected area, not just individual spots.
- Apply to clean, dry skin, usually once daily at bedtime.
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer. Avoid harsh soaps, astringents, or abrasive products.
- Strictly avoid sun exposure, including tanning beds. Use a broad-spectrum sunscreen (SPF 30 or higher) daily and wear protective clothing (hats, long sleeves) when outdoors, even on cloudy days. Tretinoin increases sun sensitivity.
- Initial worsening of acne ('purging') is common and temporary; continue treatment.
- Be patient; it can take 6-12 weeks to see significant improvement.
- Do not use if pregnant, planning to become pregnant, or breastfeeding without consulting your doctor.
Available Forms & Alternatives
Available Strengths:
- Retin-A 0.025% Gel 15gm
- Retin-A 0.025% Cream 20gm
- Retin-A Micro 0.08% Gel Pump 50gm
- Retin-A 0.05% Cream 20gm
- Retin-A 0.05% Cream 45gm
- Retin-A 0.025% Cream 45gm
- Retin-A 0.1% Cream 20gm
- Retin-A 0.01% Gel 15gm
- Retin-A 0.01% Gel 45gm
- Retin-A Micro 0.04% Gel 45gm
- Retin-A 0.1% Cream 45gm
- Retin-A Micro 0.1% Gel 20gm
- Retin-A 0.025% Gel 45gm
- Retin-A Micro 0.1% Gel 45gm
- Retin-A Micro 0.04% Gel Pump 50gm
- Retin-A Micro 0.1% Gel Pump 50gm
- Retin-A Micro 0.04% Gel 20gm
- Retin-A Micro 0.06% Gel Pump 50gm
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Retin-A 0.01% Gel to the affected areas once daily at bedtime.
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to the entire affected area (not just individual lesions) once daily at bedtime. A pea-sized amount is usually sufficient for the entire face.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established in children under 12 years of age.
Adolescent:
For adolescents 12 years and older, apply a thin layer to the affected areas once daily at bedtime, similar to adult dosing.
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 adjustment needed (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
Tretinoin is a retinoid that modulates epithelial cell differentiation, keratinization, and inflammation. In acne, it reduces the cohesiveness of follicular epithelial cells, leading to decreased microcomedone formation. It also stimulates mitotic activity and increased turnover of follicular epithelial cells, causing extrusion of comedones. For photoaging, it affects gene expression, leading to increased collagen synthesis and epidermal thickening.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <2-6% of applied dose)
Tmax:
Not well-defined for topical application due to minimal systemic absorption; peak plasma concentrations are very low and variable.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical due to minimal systemic absorption.
ProteinBinding:
Highly protein bound (>95%) if systemically absorbed.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not well-defined for topical; if systemically absorbed, plasma half-life is short (e.g., 0.5-2 hours).
Clearance:
Rapid hepatic clearance if systemically absorbed.
ExcretionRoute:
Primarily renal and biliary excretion of metabolites.
Unchanged:
Negligible amount excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Initial improvement typically seen within 2-3 weeks, but optimal results may take 6-12 weeks.
PeakEffect:
Peak therapeutic effect for acne usually observed after 6-12 weeks of continuous use.
DurationOfAction:
Effects persist with continued use; relapse may occur upon discontinuation.
Confidence:
High
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 immediately or seek emergency 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
A severe skin reaction that is bothersome or persistent
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, such as:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling
If you develop any skin reactions, consult your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of application.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 immediately or seek emergency 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
A severe skin reaction that is bothersome or persistent
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, such as:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling
If you develop any skin reactions, consult your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of application.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 redness, swelling, blistering, or crusting of the skin (contact your doctor immediately)
- Excessive burning or stinging that does not subside
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Medications that may increase your skin's sensitivity to light, as many drugs can have this effect. If you are unsure, consult your doctor or pharmacist for guidance.
Additionally, if you are pregnant, notify your doctor, as this may impact your treatment.
To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
This information will help your doctor determine whether it is safe 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 symptoms you experienced.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Medications that may increase your skin's sensitivity to light, as many drugs can have this effect. If you are unsure, consult your doctor or pharmacist for guidance.
Additionally, if you are pregnant, notify your doctor, as this may impact your treatment.
To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
This information will help your doctor determine whether it is safe 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. If you have a fish allergy, consult your doctor before using this product, as some formulations may contain fish protein.
Please note that it may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, it is crucial to adhere to your doctor's instructions regarding dosage and frequency of use. Do not exceed the recommended amount or use it for an extended period beyond what your doctor has prescribed.
When applying this medication, avoid using it on sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and take precautions to protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so it is recommended to avoid direct sunlight, sunlamps, and tanning beds. When going outside, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, and wear protective clothing and eyewear.
Additionally, be aware that certain weather conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on how to protect your skin in these situations. It is also important to avoid contact with lime peels while using this medication.
Using other skin products in conjunction with this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult your doctor to discuss potential interactions. If you experience dry skin as a result of using this medication, you may use a moisturizer. However, consult your doctor or pharmacist to determine the most suitable type of moisturizer for your skin.
You may use makeup while using this medication, unless your doctor has advised against it. If you do plan to use makeup, ensure that you clean the area to be treated before applying the medication.
In case of accidental ingestion, this medication can be harmful. If you or someone else swallows this medication, immediately contact a doctor or a poison control center.
If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you suspect you may be pregnant or are planning to become pregnant while taking this medication, contact your doctor right away.
If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.
Please note that it may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, it is crucial to adhere to your doctor's instructions regarding dosage and frequency of use. Do not exceed the recommended amount or use it for an extended period beyond what your doctor has prescribed.
When applying this medication, avoid using it on sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and take precautions to protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so it is recommended to avoid direct sunlight, sunlamps, and tanning beds. When going outside, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, and wear protective clothing and eyewear.
Additionally, be aware that certain weather conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on how to protect your skin in these situations. It is also important to avoid contact with lime peels while using this medication.
Using other skin products in conjunction with this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult your doctor to discuss potential interactions. If you experience dry skin as a result of using this medication, you may use a moisturizer. However, consult your doctor or pharmacist to determine the most suitable type of moisturizer for your skin.
You may use makeup while using this medication, unless your doctor has advised against it. If you do plan to use makeup, ensure that you clean the area to be treated before applying the medication.
In case of accidental ingestion, this medication can be harmful. If you or someone else swallows this medication, immediately contact a doctor or a poison control center.
If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you suspect you may be pregnant or are planning to become pregnant while taking this medication, contact your doctor right away.
If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Local symptoms of excessive application may include severe redness, peeling, discomfort, and irritation.
What to Do:
If excessive application occurs, discontinue use temporarily. If severe local irritation, apply a soothing moisturizer. If accidental ingestion occurs, contact a poison control center or emergency medical services. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Moderate Interactions
- Concomitant use with other topical preparations that are irritating, drying, or contain strong peeling agents (e.g., sulfur, resorcinol, salicylic acid) should be avoided or used with caution due to additive irritant effects.
- Concomitant use with products containing alpha hydroxy acids (AHAs) or beta hydroxy acids (BHAs) may increase irritation.
- Concomitant use with photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) may increase risk of photosensitivity.
Minor Interactions
- Astringents, medicated soaps or cleansers, abrasive soaps or cleansers, cosmetics with a strong drying effect, and products with high concentrations of alcohol, spices, or lime may cause increased irritation.
Monitoring
Baseline Monitoring
Skin assessment (type, condition, presence of lesions, irritation)
Rationale: To establish baseline skin health and severity of condition (acne, photoaging) and identify potential contraindications or sensitivities.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin response (redness, peeling, dryness, burning, itching)
Frequency: Daily during initial weeks, then as needed.
Target: Mild to moderate irritation is common and expected; severe or persistent irritation requires intervention.
Action Threshold: If severe irritation (e.g., excessive redness, swelling, blistering, crusting) occurs, reduce frequency of application or temporarily discontinue use. Consult physician if symptoms persist.
Therapeutic efficacy (reduction in lesions, improvement in skin texture)
Frequency: Monthly or as clinically indicated.
Target: Gradual improvement over weeks to months.
Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of treatment plan.
Symptom Monitoring
- Excessive dryness
- Peeling or flaking of skin
- Redness (erythema)
- Burning or stinging sensation
- Itching
- Swelling
- Blistering or crusting (rare, indicates severe irritation)
- Increased sensitivity to sunlight
Special Patient Groups
Pregnancy
Tretinoin topical is Pregnancy Category C. While systemic absorption is minimal, oral retinoids are highly teratogenic. Therefore, use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
Potential risk of teratogenicity, especially during organogenesis, though systemic exposure from topical application is very low. Avoid if possible.
Second Trimester:
Risk considered lower than first trimester, but still generally advised to avoid.
Third Trimester:
Risk considered lower than first trimester, but still generally advised to avoid.
Lactation
Minimal systemic absorption of topical tretinoin makes transfer into breast milk unlikely to be clinically significant. However, caution is advised. If used, avoid applying to areas where the infant may come into direct contact with the medication (e.g., chest).
Infant Risk:
Low risk (L3 - Moderately Safe, due to theoretical concerns and lack of extensive data, but minimal absorption suggests low actual risk).
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 12 years of age. Use in adolescents (12 years and older) is similar to adult dosing for acne vulgaris.
Geriatric Use
No specific dosage adjustments are required. However, geriatric patients may have more fragile or sensitive skin, potentially leading to increased irritation. Use with caution and monitor for excessive dryness or irritation.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.01% or 0.025%) and gradually increase as tolerated to minimize irritation.
- Apply to completely dry skin (wait 20-30 minutes after washing) to reduce irritation.
- A 'pea-sized' amount is typically sufficient for the entire face. Using more will not speed up results and will likely increase irritation.
- The 'purging' phase (initial worsening of acne) is common and temporary; encourage patients to continue treatment.
- Emphasize consistent daily sunscreen use (SPF 30+) and sun avoidance, as tretinoin significantly increases photosensitivity.
- Combine with a gentle, non-comedogenic moisturizer to combat dryness and irritation.
- Avoid waxing on treated areas as skin may be more fragile and prone to tearing.
Alternative Therapies
- Other topical retinoids (e.g., adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Azelaic acid
- Salicylic acid
- Oral antibiotics (for moderate to severe acne)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for hormonal acne)
Cost & Coverage
Average Cost:
$50 - $200+ per 15gm tube (generic); brand can be significantly higher
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (generic often preferred)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.