Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR CLARIFYING- salicylic acid solution

  • NDC Code(s): 49967-024-01, 49967-024-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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

  • Active ingredient

    Salicylic acid 0.5%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

  • 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.

  • 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
  • Other information

    Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

  • Inactive ingredients

    water, alcohol denat., propanediol, glycolic acid, sodium hydroxide, capryloyl glycine, phenoxyethanol, benzyl alcohol, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, menthol, tremella fuciformis polysaccharide, butylene glycol, ophiopogon japonicus root extract, scutellaria baicalensis root extract

  • Questions or comments?

    1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR CLARIFYING 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    MENTHOL (UNII: L7T10EIP3A)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-024-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2014
    2NDC:49967-024-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00608/01/2014
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-024)