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
  • 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 September 2, 2020

If you are a consumer or patient please visit this version.

  • 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 carton

  • 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) , pack(49967-076)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458analysis(49967-076)