Label: ACNE THERAPY- benzoyl peroxide lotion
- NDC Code(s): 71397-822-55
- Packager: menScience Androceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 11, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses
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Warnings
For external use only.
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.
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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 C (68-77 F) oo
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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:
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INGREDIENTS AND APPEARANCE
ACNE THERAPY
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71397-822 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 30 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) UREA (UNII: 8W8T17847W) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) STEARETH-20 (UNII: L0Q8IK9E08) PEG-100 STEARATE (UNII: YD01N1999R) STARCH, CORN (UNII: O8232NY3SJ) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TOCOPHEROL (UNII: R0ZB2556P8) ASCORBYL PALMITATE (UNII: QN83US2B0N) .BETA.-CAROTENE (UNII: 01YAE03M7J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIMETHICONE (UNII: 92RU3N3Y1O) STEARETH-2 (UNII: V56DFE46J5) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PANTHENOL (UNII: WV9CM0O67Z) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ALLANTOIN (UNII: 344S277G0Z) PHYTONADIONE (UNII: A034SE7857) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71397-822-55 45 g in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 04/20/2017 Labeler - menScience Androceuticals, LLC (017390110)