Acne Treatment Gel
FDA Label NDC 31720-301
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by S+ for the product Acne Treatment Gel (NDC 31720-301). 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 ingredient, purpose, use, warnings, when using this product, 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 Ingredient
Salicylic acid 2%
Purpose
Acne treatment
Use
For the treatment of acne
Warnings
For external use only
When Using This Product
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.
If swallowed, get medical help or contact a Poison Control Center right away.
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 or three 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
Inactive Ingredients
Water (aqua), pentylene glycol, biberry (Vaccinium myrtilus) fruit extract, xanthan gum, sodium hydroxide, sugarcane (Saccharum officinarum) extract, glycerin, saccharide isomerate, orange (Citrus sinensis) fruit extract, lemon (Citrus x limon) fruit extract, sugar maple (Acer saccharum) extract, hydrolyzed algin, citric acid, sodium citrate, zinc sulfate.
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