Otc - Active Ingredient
Active Ingredient
Benzoyl Peroxide 5%
Purpose
Acne Treatment
Anti Bac Acne Clearing Lotion
FDA Label NDC 56152-4012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Enterprise Ltd for the product Anti Bac Acne Clearing (NDC 56152-4012). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, 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
Use
- For the treatment of acne
- Helps keep skin clear of new acne blemishes
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if irritation becomes severe.
Warnings
Warnings
For external use only
- When using this product
- 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.
- Do not use this product if you have very sensitive skin or if you are sensitive to Benzoyl Peroxide.
- Avoid unnecesary sun exposure and use a sunscreen
- Avoid contact with the eyes, lips, and mouth.
- Avoid contact with hair and dyed fabrics, which may be bleached by this product
- Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Dosage & Administration
Directions
- Clease Skin thoroughly before applying. Cover the affected area with a thin layer 1 to 3 days. 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 by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- If going outside apply sunscreen after using this product. If irritation or sensitivity develops, stop use of products and ask a doctor.
Inactive Ingredient
Inactive Ingredients
Water/Aqua/Eau, PPG-2 Myristyl Ether Propionate, Argania Spinosa Kernel Extract, PEG-40 Sterate, Serenoa Serrulata Fruit Extract, Sesamum Indicum (sesame) Seed Extract, Alcohol Denat., Sorbitan Stearate, Hydrogenated Methyl Abeitate, Methyl Methacrylate Crosspolymer, Carbomer, Glyceryl Stearate, Cetyl Alcohol, Tetrasodium EDTA, Hydrogenated Lecithin, Cholesterol, Ceramide NS, Ceramide NP, Oleic Acid, Plamitic Acid, Sodium Ascorbate, Sodium Hydroxide, EDTA, Ethylhexylglycerin, Phenoxyethanol
Package Label.Principal Display Panel
Kate Somerville
Acne/Peau acneique
5% Benzoyl Peroxide
Anti Bac
Acne Clearing Lotion
Lotion purifiante actibacterienne
50mL 1.7 Fl Oz Liq
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