Acne Therapy Lotion
FDA Label NDC 71397-822
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Menscience Androceuticals, Llc for the product Acne Therapy (NDC 71397-822). 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, uses, warnings, do not use:, when using this product:, discontinue use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzoyl Peroxide 3%
Purpose
Acne Treatment
Uses
for the treatment and prevention of acne
Warnings
For external use only.
Do Not Use:
If you have very sensitive skin or sensitive to benzoyl peroxide.
When Using This Product:
Apply to affected areas only. Avoid unnecessary sun exposure and use a sunscreen. Do not use in or near the eyes, lips or mouth. This product may bleach hair or dyed fabrics. Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin.
Discontinue Use And Ask A Doctor
if skin irritation becomes severe or if you are using more than one acne medication.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a poison control center right away.
Directions:
Shake before using. Apply to clean skin. Cover the affected area with a thin layer 1 to 3 times daily. Because too much drying of the skin may occur, start with 1 application daily or every other day, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce applicaction once a day or every other day. If going outside, allow product to dry, then use a sunscreen. Store at 20-25 oC (68-77 oF)
Inactive Ingredients
Aqua purificata (purified water), C12-15 Alkyl Benzoate, Urea, Butylene Glycol, Cyclopentasiloxane, Magnesium aluminum silicated, Steareth-20, Peg-100 stearate, Zea mays (corn) starch, Hydroxyethyl acrylate/sodium acryloydimethyl, Taurate copolymer, Squalane, Polysorbate 60, Chamomilla recutita (matricaria) extract, Camellia oleifera leaf extract, Phospholipids, Retinyl palmitate, Tocopherol, Ascorbyl palmitate, Beta-carotene, Ethylhexylglycerin, Cetearyl alcohol, Glycerin, Caprylyl glycol, Dimethicone, Acrylates/C10-30 alkyl acrylate crosspolymer, Steareth-2, Butylene Glycol, Propylene glycol, Panthenol, Disodium EDTA, Allantoin, Phytonadione.
Package Labeling:
Label (Label)
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