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
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 11, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
-
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
-
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
-
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 FINAL part333D 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)
