LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [L'OREAL USA, INC.]

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [L'OREAL USA, INC.]
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NDC 49967-076-01, 49967-076-02, 49967-076-03
Set ID 8ed6ee51-816e-4c83-a437-4ceaa339b130
Category HUMAN OTC DRUG LABEL
Packager L'OREAL USA, INC.
Generic Name
Product Class
Product Number
Application Number PART333D
  • Active ingredient

    Benzoyl peroxide 5.5%

  • Purpose

    Acne medication

  • Uses

    • for the treatment of acne
    • dries and clears acne blemishes and allows skin to heal
  • 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    store at 20 - 25 C (68 to 77 F)

  • Inactive ingredients

    water, isostearyl alcohol, glycerin, pentylene glycol, silica, carbomer, capryloyl salicylic acid, potassium hydroxide, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, epilobium angustifolium flower/leaf/stem extract

  • Questions or comments?

    1-888-LRP-LABO 1-888-577-5226

    Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl peroxide (UNII: W9WZN9A0GM) (Benzoyl peroxide - UNII:W9WZN9A0GM) Benzoyl peroxide55 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-076-011 in 1 CARTON07/01/2012
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-076-021 in 1 CARTON07/01/2012
    220 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:49967-076-033 mL in 1 PACKET; Type 0: Not a Combination Product07/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2012
    Labeler - L'OREAL USA, INC. (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beauty Manufacturing Solutions Corp.783200723manufacture(49967-076)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-076)

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