Label: AGE INTERVENTION DUALITY MD- benzoyl peroxide cream
- NDC Code(s): 65113-2373-2
- Packager: G.S. COSMECEUTICAL USA, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 15, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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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.
When using this product
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- avoid contact with the eyes, lips and mouth
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
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DIRECTIONS
- Clean the skin thoroughly before applying this product.
- This product contains two parts. Dispense equal quantities of product from each of the two pumps, then briefly mix the two parts together on your palm.
- 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 physician.
- 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 both products and ask a physician.
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 28 g Carton
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INGREDIENTS AND APPEARANCE
AGE INTERVENTION DUALITY MD
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65113-2373 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLYSORBATE 60 (UNII: CAL22UVI4M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) RETINOL (UNII: G2SH0XKK91) SORBITOL (UNII: 506T60A25R) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) CHRYSIN (UNII: 3CN01F5ZJ5) DIMETHICONE (UNII: 92RU3N3Y1O) STEARETH-20 (UNII: L0Q8IK9E08) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Product Characteristics Color YELLOW (VERY PALE YELLOW) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65113-2373-2 28 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M006 05/01/2011 Labeler - G.S. COSMECEUTICAL USA, INC. (017014734) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(65113-2373)
