Otc - Active Ingredient
Active Ingredient:
Salicylic Acid 2%
Anti-acne
FDA Label NDC 59735-312
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biocosmetics Research Labs for the product Anti-acne (NDC 59735-312). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, precautions, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:
Acne Treatment Cream
Indications & Usage
Use:For the treatment of acne. Clears up most of the acne blemishes, acne pimples, blackheads or whiteheads.
Warnings
Warnings:
For external use only.
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, only one medication should be used unless directed by a doctor.
Dosage & Administration
Directions:Cleanse the skin thoroughly before applying the medication. Cover the entire affected area with a thin layer 1-2 times daily. Because excessive drying of the skin may occur, start with one application every other day, then gradually increase. If bothersome dryness or peeling occurs, reduce application to once every other few days.
Precautions
Sensitivity test for new user:
Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Inactive Ingredient
Other Ingredients:
Water, Methyl Gluceth-20, Isopropyl Myristate, Sorbitan Stearate, Cetyl Alcohol, Alcohol Denat, Triethanolamine, Caprylic/Capric Triglyceride, Dimethicone,
Sodium Polyacrylate, Ceteareth-20, Butylene Glycol, Ethylhexyl Stearate, Capryloyl Glycine, Sarcosine, Cinnamomum Zeylanicum Bark Extract, Mel (Honey Extract), Trideceth-6, Retinyl Palmitate, Tocopheryl Acetate, Hydroxyethylcellulose, Arnica Montana Flower Extract, Xanthan Gum, Disodium EDTA, Diazolidinyl Urea, Iodopropynyl Butylcarbamate.
Package Label.Principal Display Panel
Image Of Carton For Anti Acne Lotion (Acnelotion)
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