Retin-A 0.05% Cream 20gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent; Keratolytic
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Retin-A 0.05% Cream is a topical medication containing tretinoin, a form of vitamin A. It's primarily used to treat acne by helping skin cells turn over more quickly and preventing pores from clogging. It can also improve the appearance of fine wrinkles and dark spots by promoting 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 accompanying information carefully. 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 the 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.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
* If you miss a dose, skip it and resume your regular 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 accompanying information carefully. 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 the 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.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
* If you miss a dose, skip it and resume your regular 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 contact with eyes, mouth, angles of the nose, and mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer.
- Sun sensitivity is significantly increased; use broad-spectrum sunscreen (SPF 30+) daily and wear protective clothing.
- Avoid excessive sun exposure, sunlamps, and tanning beds.
- Initial worsening of acne (purging) is common during the first few weeks of treatment.
- Be patient; it can take 6-12 weeks to see significant improvement for acne, and longer for anti-aging effects.
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 to affected areas once daily at bedtime
Condition-Specific Dosing:
Acne Vulgaris:
Apply a thin layer to affected areas once daily at bedtime, after washing and drying the skin. Start with lower concentrations (e.g., 0.025%) and gradually increase as tolerated. 0.05% cream is a moderate strength.
Fine Wrinkles/Hyperpigmentation:
Apply a thin layer to affected areas once daily at bedtime. Use as directed by a physician, often for longer durations.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years. Safety and efficacy not established.
Adolescent:
Apply a thin layer to affected areas once daily at bedtime for acne vulgaris (typically 12 years 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
Tretinoin is a retinoid that binds to specific retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in the nucleus, which then modulate gene expression. In acne, it decreases cohesion between follicular epithelial cells, leading to increased cell turnover and expulsion of comedones. It also reduces the formation of new comedones. For photoaging, it increases collagen synthesis, reduces epidermal melanin, and promotes epidermal cell turnover.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 1.5-5% (topical)
Tmax:
Not well-defined for topical, systemic levels are minimal and variable.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not applicable for topical administration (minimal systemic distribution)
ProteinBinding:
Highly protein bound (>95%) if systemically absorbed
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not well-defined for topical (systemic half-life is 0.5-2 hours if absorbed)
Clearance:
Not applicable for topical (systemic clearance is rapid)
ExcretionRoute:
Biliary and renal (if systemically absorbed)
Unchanged:
Not applicable (metabolized)
Pharmacodynamics
OnsetOfAction:
2-3 weeks (initial irritation/peeling), 6-12 weeks (therapeutic effect for acne)
PeakEffect:
12-24 weeks (for acne), 6-12 months (for photoaging)
DurationOfAction:
Continues as long as treatment is maintained; effects may persist for some time after discontinuation.
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 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
Severe skin reactions that are bothersome or persistent
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:
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 not mentioned here. If you have questions or concerns about side effects, 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 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
Severe skin reactions that are bothersome or persistent
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:
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 not mentioned here. If you have questions or concerns about side effects, 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:
- Severe redness, burning, stinging, or itching that does not subside.
- Excessive dryness, peeling, or flaking that is unmanageable.
- Swelling or blistering of the treated skin.
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing).
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.
Any medications you are taking that may increase your skin's sensitivity to light. There are numerous medications that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are pregnant, as this may affect the safety of taking this medication.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so with this medication.
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.
Any medications you are taking that may increase your skin's sensitivity to light. There are numerous medications that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are pregnant, as this may affect the safety of taking this medication.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Please note that it may take several weeks to experience the full effects of this drug.
To minimize the risk of severe side effects, it is crucial to follow your doctor's instructions regarding dosage and frequency of use. Do not exceed the recommended amount or use this medication more often or for a longer period than 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, as this medication may increase your susceptibility to sunburn. To reduce this risk, avoid exposure to sunlight, sunlamps, and tanning beds, and use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher when outdoors. Additionally, wear protective clothing and eyewear to shield your skin from the sun. Be aware that certain weather conditions, such as cold and wind, may irritate your skin, and 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. If you are using other skin products, be aware that they may cause increased irritation when used in conjunction with this drug. Before using any other medications or products on your skin, including soaps, consult with your doctor to discuss potential interactions.
If this medication causes dry skin, you may use a moisturizer. However, it is recommended that you consult with your doctor or pharmacist to determine the most suitable type of moisturizer for your skin. You may also use makeup unless your doctor has advised against it. If you plan to use makeup, ensure that you clean the area to be treated before applying this medication.
In case of accidental ingestion, this medication can be harmful. If you swallow this drug, immediately contact a doctor or poison control center. Furthermore, if you are pregnant or plan to become pregnant while taking this medication, inform your doctor promptly, as it may pose a risk to the unborn baby. If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
To minimize the risk of severe side effects, it is crucial to follow your doctor's instructions regarding dosage and frequency of use. Do not exceed the recommended amount or use this medication more often or for a longer period than 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, as this medication may increase your susceptibility to sunburn. To reduce this risk, avoid exposure to sunlight, sunlamps, and tanning beds, and use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher when outdoors. Additionally, wear protective clothing and eyewear to shield your skin from the sun. Be aware that certain weather conditions, such as cold and wind, may irritate your skin, and 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. If you are using other skin products, be aware that they may cause increased irritation when used in conjunction with this drug. Before using any other medications or products on your skin, including soaps, consult with your doctor to discuss potential interactions.
If this medication causes dry skin, you may use a moisturizer. However, it is recommended that you consult with your doctor or pharmacist to determine the most suitable type of moisturizer for your skin. You may also use makeup unless your doctor has advised against it. If you plan to use makeup, ensure that you clean the area to be treated before applying this medication.
In case of accidental ingestion, this medication can be harmful. If you swallow this drug, immediately contact a doctor or poison control center. Furthermore, if you are pregnant or plan to become pregnant while taking this medication, inform your doctor promptly, as it may pose a risk to the unborn baby. If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Severe local irritation (redness, peeling, discomfort)
- Unlikely to cause systemic toxicity due to minimal absorption
What to Do:
Discontinue use immediately. Wash the area with mild soap and water. Apply a soothing moisturizer. Seek medical attention if irritation is severe or persistent. For accidental ingestion, call a poison control center (1-800-222-1222) or emergency services, though systemic toxicity from topical ingestion is rare.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may increase irritation, use with caution or at different times of day)
- Astringents, abrasive soaps, medicated cleansers, or drying agents (may increase irritation)
- Products containing alcohol, menthol, spices, or lime (may cause stinging or burning)
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - increased risk of photosensitivity
Monitoring
Baseline Monitoring
Skin assessment (type, condition, presence of lesions)
Rationale: To establish baseline for efficacy and adverse effects monitoring.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (erythema, peeling, dryness, burning, stinging)
Frequency: Daily during initial weeks, then weekly/monthly
Target: Mild to moderate irritation is expected; severe irritation requires dose adjustment or temporary cessation.
Action Threshold: Severe or persistent irritation; patient discomfort affecting adherence.
Therapeutic response (reduction in acne lesions, improvement in skin texture)
Frequency: Monthly for first 3-6 months, then as needed
Target: Gradual improvement over weeks to months.
Action Threshold: No improvement after 12 weeks, or worsening condition.
Symptom Monitoring
- Excessive redness
- Severe peeling or flaking
- Intense burning or stinging
- Swelling
- Crusting
- Blistering
- Increased sensitivity to sunlight
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, oral retinoids are highly teratogenic. Caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk from topical application is considered low due to minimal systemic absorption.
Second Trimester:
Risk considered low due to minimal systemic absorption.
Third Trimester:
Risk considered low due to minimal systemic absorption.
Lactation
Use with caution. It is unknown if tretinoin is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be low. Avoid applying to areas where the infant may come into direct contact with the medication.
Infant Risk:
Low risk, but monitor for adverse effects.
Pediatric Use
Safety and efficacy not established in children under 12 years of age. Used in adolescents (12 years and older) for acne vulgaris.
Geriatric Use
No specific dose adjustments are necessary. However, geriatric patients may have more fragile or sensitive skin, increasing susceptibility to irritation. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Start low, go slow: Begin with a lower concentration (e.g., 0.025%) or apply every other night to minimize initial irritation, then gradually increase frequency or concentration as tolerated.
- The 'purge' is real: Patients often experience an initial worsening of acne (increased breakouts, redness, peeling) during the first few weeks. This is normal and indicates the medication is working; encourage patients to continue treatment.
- Sun protection is paramount: Emphasize daily, year-round use of broad-spectrum sunscreen (SPF 30+) and protective clothing due to increased photosensitivity.
- Moisturize, moisturize, moisturize: Advise patients to use a non-comedogenic, fragrance-free moisturizer frequently to combat dryness and irritation.
- Less is more: A pea-sized amount is sufficient for the entire face. Using more will not speed up results and will only increase irritation.
- Avoid waxing: Tretinoin can thin the skin, making it more prone to tearing or irritation with waxing. Advise alternative hair removal methods in treated areas.
Alternative Therapies
- Adapalene (Differin) - another topical retinoid, often better tolerated.
- Tazarotene (Tazorac) - another topical retinoid, generally stronger.
- Benzoyl Peroxide (topical)
- Salicylic Acid (topical)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Azelaic Acid
- Dapsone (topical)
Cost & Coverage
Average Cost:
$50 - $150 per 20gm tube (0.05% cream)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (generic often Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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'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 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 details about the medication taken, including the amount and time of ingestion.