Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR PORE REFINING ACNE TREATMENT- salicylic acid liquid

  • NDC Code(s): 49967-529-01, 49967-529-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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

  • Active ingredient

    Salicylic acid 1.5%

  • Purpose

    Acne treatment

  • Uses

    • clears acne blemishes
    • penetrates pores to control acne blemishes
    • helps prevent new acne blemishes from forming
  • Warnings

    For external use only

  • 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
    • children under 12 years of age: ask a doctor
  • Inactive ingredients

    water, alcohol denat., propanediol, glycolic acid, niacinamide, dimethyl isosorbide, pentylene glycol, sodium hydroxide, capitolize-26-buteth-26, PPG-26-buteth-26, hydroxyethylpiperazine ethane sulfonic acid, citric acid, PEG-30 glyceryl cocoate, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, capryloyl salicylic acid, biosaccharide gum-1, maltodextrin, phytic acid, polyquaternium-10, fragrance

  • 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 cartonimage of a carton

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  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR PORE REFINING ACNE TREATMENT 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-529
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEG-30 GLYCERYL COCOATE (UNII: FX3EB7VC3L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-529-011 in 1 CARTON05/01/2022
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:49967-529-021 in 1 CARTON05/01/2022
    23 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00605/01/2022
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMETIQUE ACTIVE PRODUCTION282658798manufacture(49967-529) , pack(49967-529)
    Establishment
    NameAddressID/FEIBusiness Operations
    Interspray364829903pack(49967-529)