Label: WET WIPES- salicylic acid swab

  • 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 January 9, 2018

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  • Active ingredient

    salicylic acid 0.5%

    Purpose

    acne treatment

  • Use

    for the treatment of acne

  • Warnings

    for external use only
    when using this product
    with other topical acne medications ,at the same time or immediately afterwards ,increased skin dryness ,redness or
    irritation may occur .If this happens ,only one medication should be used unless directed by a doctor.
    avoid contact with eyes .if contact occurs, rinse thoroughly with water. keep away from mouth and lips.
    stop use and ask doctor if skin irritation occurs.
    Keep out of reach of children ,If swallowed ,get medical help or contact a Poison Control Center immediately.

    Keep out of reach of children

    Keep out of reach of children ,If swallowed ,get medical help or contact a Poison Control Center immediately.

  • Directions

    cleanse skin thoroughly before applying medication ,remove wipe ,unfold and wipe over entire affected area.
    reseal label on package to maintain freshness.

  • INACTIVE INGREDIENT

    aqua (water),glycerin, propylene glycol , dodecyl polyglucoside, polysorbate 20,HEXYLENE GLYCOL , BENZYL ALCOHOL ,SODIUM LAURAMINOPROPIONATE ,ALOE BARBADENSIS(ALOE VERA )EXTRACT ,WHITE TEA EXTRACT ,CHAMOMILLA RECUTITA(CHAMOMILE)EXTRACT ,GLYDANT DMDM H,PHENOXYETHANOL ,PEG-40 HYDROGENATED CASTOR OIL,TOCOPHERYL ACETATE(VITAMIN E) ,DISODIUM EDTA,IODOPROPYNYL BUTYLCARBAMATE

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WET WIPES 
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61312-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DODECYL PROPIONATE (UNII: 7G537BMD9L)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM LAURAMINOPROPIONATE (UNII: X5NJA9HXPU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TEA LEAF OIL (UNII: VC855RRT77)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)  
    TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61312-004-0135 in 1 BAG01/01/2018
    10.00054 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B02/25/2015
    Labeler - HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. (526890634)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.526890634manufacture(61312-004)
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