Drug Facts
Drug Facts
The Acne Spot Treatment Gel
FDA Label NDC 87415-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spotless, Inc. for the product The Acne Spot Treatment (NDC 87415-100). 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 drug facts, active ingredients, purpose, uses, warnings, otc - when using, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Salicylic Acid 2%
Purpose
Acne Medication
Uses
• for treatment of acne
Warnings
For external use only
Flammable, keep away from open fire or flame
Otc - When Using
When using this product skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Directions
• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer one to three times daily
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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
• Always wear sunscreen after daytime use
Inactive Ingredients
Water, Niacinamide, Glycerin, Pentylene Glycol, Sodium Polyacrylate, Polyacrylate Crosspolymer-6, Epigallocatechin Gallatyl Glucoside, Epigallocatechin Gallate, Madecassoside, Zinc PCA, Sphingomonas Ferment Extract, Panthenol, Sodium Polyacryloyldimethyl Taurate, Caprylyl Glycol, Ethylhexylglycerin, Tocopherol
Package Label.Principal Display Panel
Dramywechsler_spottreatment_carton_012726_print (Dramywechsler Spottreatment Carton 012726 Print)
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