FDA Label for Replenix Acne
View Indications, Usage & Precautions
Replenix Acne Product Label
The following document was submitted to the FDA by the labeler of this product Topiderm, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
- For external use only.
- Keep away from eyes, lips, and mouth.
- If irritation develops, discontinue use and consult a doctor.
- Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, consult a doctor.
- May bleach fabrics.
Active Ingredient
Benzoyl Peroxide, USP 5%
Purpose
Anti-acne
Uses
- Topical acne medication.
Otc - When Using
- When using this product avoid unnecessary sun exposure and use a sunscreen.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
Directions
- Cleanse the skin thoroughly before applying.
- Apply a thin layer daily, then gradually increase to two or three times daily.
- If bothersome drying or peeling occurs, reduce applications.
- If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.
Inactive Ingredients
Carbomer, Purified Water, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Stearic Acid.
Principal Display Panel - 57 G Tube Label
REPLENiX®
ACNE SOLUTIONS
Acne Gel
Benzoyl Peroxide USP, 5%
Net wt. 2 oz. (57 g)
Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701
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