Label: CETAPHIL GENTLE CLEAR BPO ACNE CLEANSER- benzoyl peroxide cream
- NDC Code(s): 0299-4125-00, 0299-4125-05
- Packager: Galderma Laboratories, L.P.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 29, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only.
Do not use if you
■ Have very sensitive skin
■ Are sensitive to benzoyl peroxide
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. ■ avoid unnecessary 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 possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.Stop use and ask a doctor if
■ Irritation becomes severe - KEEP OUT OF REACH OF CHILDREN
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Directions
■ Gently massage a dime-size amount onto dampened skin for 20 – 30 seconds, avoiding the eye area. Rinse thoroughly and pat dry. Can be used twice daily or as directed 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 both products and ask a doctor.
- Inactive Ingredients
- STORAGE AND HANDLING
- Questions or comments?
- QUESTIONS
- Principle Display Panel - 4.2 FL OZ tube
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INGREDIENTS AND APPEARANCE
CETAPHIL GENTLE CLEAR BPO ACNE CLEANSER
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-4125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 2.6 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Glycerin (UNII: PDC6A3C0OX) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Laureth-2 (UNII: D4D38LT1L5) Phenoxyethanol (UNII: HIE492ZZ3T) Xanthan Gum (UNII: TTV12P4NEE) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Poloxamer 124 (UNII: 1S66E28KXA) Zinc Gluconate (UNII: U6WSN5SQ1Z) Edetate Disodium (UNII: 7FLD91C86K) Citric Acid Monohydrate (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0299-4125-00 124 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2022 2 NDC:0299-4125-05 12 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 05/01/2022 Labeler - Galderma Laboratories, L.P. (047350186) Establishment Name Address ID/FEI Business Operations G Production Inc. 251676961 manufacture(0299-4125)
