Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT- benzoyl peroxide lotion
- NDC Code(s): 49967-076-01, 49967-076-02, 49967-076-03
- Packager: L'OREAL USA, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 31, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use if you
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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
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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
- Keep out of reach of children.
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Directions
- clean the skin thoroughly before applying this product
- 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 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 prdoucts and ask a doctor.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-076 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl peroxide (UNII: W9WZN9A0GM) (Benzoyl peroxide - UNII:W9WZN9A0GM) Benzoyl peroxide 55 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-076-01 1 in 1 CARTON 07/01/2012 1 40 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-076-02 1 in 1 CARTON 07/01/2012 2 20 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:49967-076-03 3 mL in 1 PACKET; Type 0: Not a Combination Product 07/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 07/01/2012 Labeler - L'OREAL USA, INC. (002136794) Establishment Name Address ID/FEI Business Operations Beauty Manufacturing Solutions Corp. 783200723 manufacture(49967-076) , pack(49967-076) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 analysis(49967-076)
