Label: DIFFERIN MAX STRENGTH ACNE FOAMING BPO CLEANSER- benzoyl peroxide solution
- NDC Code(s): 0299-4137-00
- Packager: Galderma Laboratories, L.P.
- 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.
Updated May 18, 2023
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- Active Ingredients
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
■ Wet face and gently massage all over face for about 20 – 30 seconds, avoiding the eye area. Rinse thoroughly and pat dry. ■ 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 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?
- Principle Display Panel - 5 FL OZ carton
INGREDIENTS AND APPEARANCE
DIFFERIN MAX STRENGTH ACNE FOAMING BPO CLEANSER
benzoyl peroxide solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-4137 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 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0299-4137-00 1 in 1 BOX 04/11/2023 1 148 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 04/11/2023 Labeler - Galderma Laboratories, L.P. (047350186) Establishment Name Address ID/FEI Business Operations G Production Inc. 251676961 manufacture(0299-4137)