Active Ingredients
Gelatin 20%
Acne Patch
FDA Label NDC 84766-0003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Comfmet Limited for the product Acne Patch (NDC 84766-0003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children, description, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne treatment
Uses
treats and helps prevent acne
Warnings
For external use only
When using this product
keep away from eyes, lips and mouth. lf contact occurs, flush thoroughly with water.
skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time If irritation occurs, only use one topical acne medication at a time.
Keep Out Of Reach Of Children
lf pregnant or breast-feeding,ask a healthcare professional before use. lf accidental ingestion and adverse reaction occurs, get medical help or contact a Poison Control Center.
Description
cleanse skin thoroughly before applying this product
apply patch(es) to affected area(s)
to remove, gently peel back patch and discard
because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
if bothersome dryness or peeling occurs, reduce application to once a day or every other day
Other Information
store in a cool dry place, away from direct sunlight.
Inactive Ingredient
Sodium carboxy methyl cellulose,
Dioctyl adipate,
Hot melt adhesive,
Polyurethane film,
Polyethylene terephthalate,
Otc - Questions
Email: [email protected]
Dosage & Administration
After washing face, apply directly to the pimple, once in the morning and once in the evening
Package Label.Principal Display Panel
2 (E0a22a03aded7b0e2d13f15a8bc67c0)
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