Label: CLEAR PROOF CLARIFYING CLEANSING GEL ACNE MEDICATION- salicylic acid gel

  • NDC Code(s): 51531-1349-1, 51531-1349-4
  • Packager: Mary Kay Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active ingredient

    Salicylic Acid (2% W/W)

    Purpose

    Acne Medication

  • Uses

    • for the management of acne
    • helps prevent new acne pimples
  • 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.
    • avoid contact with the eyes

    Stop use and ask a doctor if

    irritation or sensitivity develops or increases

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • cleanse skin thoroughly before applying medication
    • cover the entire affected area with a thin layer and rinse thoroughly 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
  • Inactive ingredients

    arctium lappa root extract, butylene glycol, citric acid, cocamidopropyl betaine, cystoseira amentacea/caespitosa branchycarpa extract, disodium EDTA, DMDM hydantoin, epilobium angustifolium flower/leaf/stem extract, ethylparaben, glycerin, methylparaben, phenoxyethanol, propylene glycol, propylparaben, sodium C14-16 olefin sulfonate, sodium chloride, triethanolamine, water

  • Principal Display Panel - 127 g carton

    clearproof

    clarifying cleansing gel

    acne medication

    2% salicylic acid

    4.5 OZ. NET WT. / 127 g

    Mary Kay

    image of carton

  • INGREDIENTS AND APPEARANCE
    CLEAR PROOF CLARIFYING CLEANSING GEL  ACNE MEDICATION
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-1349
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51531-1349-41 in 1 CARTON08/15/2013
    1127 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51531-1349-128 g in 1 TUBE; Type 0: Not a Combination Product08/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00608/15/2013
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Port Jervis Laboratories Inc.001535103manufacture(51531-1349)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-1349)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab Inc.172198223pack(51531-1349)
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