LA ROCHE POSAY LABORATORIE DERMATOLOGIQUE EFFACLAR MEDICATED CLEANSER (SALICYLIC ACID) GEL [L'OREAL USA PRODUCTS INC]

LA ROCHE POSAY LABORATORIE DERMATOLOGIQUE EFFACLAR MEDICATED CLEANSER (SALICYLIC ACID) GEL [L'OREAL USA PRODUCTS INC]
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NDC 49967-023-01, 49967-023-02
Set ID 8a6e2634-2497-403a-af03-113bf35fe36a
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART333D
  • 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, PEG-150 pentaerythrityl tetrastearate, hexylene glycol, sodium hydroxide, PEG-6 caprylic/capric glycerides, zinc gluconate, tetrasodium EDTA, polyquaternium-47, menthol, capryloyl salicylic acid, citric acid

  • Questions or comments?

    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 LABORATORIE DERMATOLOGIQUE EFFACLAR MEDICATED CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-023
    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)  
    PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    MENTHOL (UNII: L7T10EIP3A)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-023-01200 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2014
    2NDC:49967-023-02100 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/01/2014
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-023)

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