Label: LA ROCHE POSAY EFFACLAR MEDICATED CLEANSER- salicylic acid gel

  • NDC Code(s): 49967-402-01, 49967-402-02, 49967-402-03
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 2024

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  • Active ingredient

    Salicylic acid 2%

  • 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

    • use twice daily
    • wet face, then work product into a lather
    • massage onto face, avoiding the eyes
    • rinse well
  • Inactive ingredients

    water, sodium laureth sulfate, decyl glucoside, glycerin, sodium chloride, coco-betaine, sodium hydroxide, PEG-150 pentaerythrityl tetrastearate, citric acid, hexylene glycol, PEG-6 caprylic/capric glycerides, zinc gluconate, tetrasodium EDTA, polyquaternium-47, menthol, capryloyl salicylic acid, sodium benzoate

  • Questions or comments?

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  • PRINCIPAL DISPLAY PANEL

    image of a label

    image of a label
  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY EFFACLAR MEDICATED CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYQUATERNIUM-47 (METHACRYLAMIDOPROPYLTRIMETHYLAMMONIUM CHLORIDE-CO-METHYL ACRYLATE-CO-ACRYLIC ACID 46:8:46; 1300000 MW) (UNII: G938900MID)  
    MENTHOL (UNII: L7T10EIP3A)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-402-01200 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2022
    2NDC:49967-402-02100 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2022
    3NDC:49967-402-0315 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00608/01/2022
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-402) , pack(49967-402)
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