Label: LA ROCHE-POSAY EFFACLAR DUO DUAL ACTION ACNE TREATMENT- benzoyl peroxide lotion
- NDC Code(s): 11090-223-01, 11090-223-02, 11090-223-03
- Packager: Beauty Manufacturing Solutions Corp
- 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 February 11, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
-
WHEN USING
- 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
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
- 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.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LA ROCHE-POSAY EFFACLAR DUO DUAL ACTION ACNE TREATMENT
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-223 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 EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT) CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) WATER (UNII: 059QF0KO0R) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) PENTYLENE GLYCOL (UNII: 50C1307PZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11090-223-01 20 in 1 CARTON 07/01/2012 1 3 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11090-223-02 1 in 1 CARTON 07/01/2012 2 20 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:11090-223-03 1 in 1 CARTON 07/01/2012 3 40 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 07/01/2012 Labeler - Beauty Manufacturing Solutions Corp (783200723) Registrant - Beauty Manufacturing Solutions Corp (783200723) Establishment Name Address ID/FEI Business Operations Beauty Manufacturing Solutions Corp 783200723 manufacture(11090-223)
