Label: WET WIPES- phenoxyethanol swab

  • NDC Code(s): 78936-002-01
  • Packager: Hangzhou Caring Cleaning Commodity Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL

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 June 17, 2020

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  • Active Ingredient(s)

    Quaternary ammonium, Phenoxyethanol

  • Purpose

    Antiseptic

  • Use

    Decreases bacteria on skin. Recommended for repeated use

  • Warnings

    For external use only. Flammable, keep product away from fire or flame.

    Do not use over large areas of the body if you are allergic to any of the ingredients when using this product,avoid contact with eyes and face.If contact occurs,flush thoroughly with water.Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Inactive ingredients

    Water,Glycerin，Polysorbate 20，Aloe Barbadensis Leaf Extract，Chamomilla Recutita (Matricaria) Flower Extract，Tocopheryl Acetate，Citric Acid

  • Directions

    For adults and children of 2 years and over.children under 2 years ask a doctor before use.

    Wet hands thoroughly with product and allow to dry without wiping.

  • Package Label - Principal Display Panel

    100 PCS IN 1 PAIL NDC: 78936-002-01

    Label

  • INGREDIENTS AND APPEARANCE
    WET WIPES 
    phenoxyethanol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78936-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3 g  in 100 g
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78936-002-01100 g in 1 PAIL; Type 0: Not a Combination Product06/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34706/18/2020
    Labeler - Hangzhou Caring Cleaning Commodity Co.,Ltd (413905445)
    Registrant - Hangzhou Caring Cleaning Commodity Co.,Ltd (413905445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Caring Cleaning Commodity Co.,Ltd413905445manufacture(78936-002)
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