COMPOSITION
- Active Ingredient: Tretinoin 0.025% (0.25 mg per gram)
- Inactive Ingredients: Alcohol, purified water, hydroxypropyl cellulose, butylated hydroxytoluene
DESCRIPTION
Retin-A Gel 0.025% is a topical gel formulation of tretinoin, a retinoid (vitamin A derivative) primarily used for the treatment of acne vulgaris and photoaging. It stimulates skin cell turnover to clear clogged pores and reduce acne breakouts.
INDICATIONS AND USAGE
Retin-A Gel 0.025% is indicated for:
- Treatment of acne vulgaris.
- Management of fine facial wrinkles, hyperpigmentation, and rough skin in adults.
DOSAGE AND ADMINISTRATION
- For acne treatment: Apply once daily at bedtime or as directed by your physician.
- Clean and dry the affected area before application. Use a small amount (pea-sized) to cover the entire affected area lightly.
- Avoid contact with eyes, lips, and mucous membranes.
- Use sunscreen and wear protective clothing during the day as tretinoin increases sensitivity to sunlight.
CONTRAINDICATIONS
- Hypersensitivity to tretinoin or any component of the formulation.
WARNINGS AND PRECAUTIONS
- Photosensitivity: Increased sensitivity to sunlight and UV light may occur. Use a broad-spectrum sunscreen (SPF 30 or higher) and limit sun exposure.
- Irritation: May cause redness, peeling, dryness, or burning, particularly in the early weeks of treatment.
- Use with caution in pregnant women. Safety in pregnancy is not well established (Pregnancy Category C).
- Avoid concurrent use of other potentially irritating topical agents, including harsh soaps, abrasive cleansers, and products with high alcohol content.
- Not for use in patients with eczema or rosacea without medical supervision.
ADVERSE REACTIONS
Common side effects include:
- Redness
- Dryness
- Itching
- Burning or stinging sensation
- Peeling or flaking of the skin
- Temporary worsening of acne during the first few weeks of use
If severe irritation occurs, discontinue use and consult your healthcare provider.
DRUG INTERACTIONS
- Use of other topical medications, particularly those with drying effects (e.g., benzoyl peroxide, salicylic acid), may increase irritation.
- Avoid products that cause photosensitivity, such as certain antibiotics (e.g., tetracyclines).
PREGNANCY AND LACTATION
- Pregnancy Category C: Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- It is unknown whether tretinoin is excreted in human milk. Caution should be exercised when administered to nursing mothers.
OVERDOSAGE
Excessive application may result in marked redness, peeling, and discomfort. In case of accidental ingestion, seek immediate medical assistance.
STORAGE AND HANDLING
- Store at room temperature (20°C to 25°C / 68°F to 77°F).
- Keep out of reach of children.
- Keep tightly closed and away from excessive heat and direct sunlight.