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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 24, 2023

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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 finalM00608/15/2013
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Port Jervis Laboratories Inc.001535103manufacture(51531-1349)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab Inc.172198223pack(51531-1349)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-1349)