Label: GENTLE BEAST ANTISEPTIC WIPES- isopropyl alcohol swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 16, 2021

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  • ACTIVE INGREDIENT

    Isopropyl Alcohol

  • INACTIVE INGREDIENT

    Butylene Glycol, Cetylpyridinium chloride, Citric Acid, Glycerin, Polysorbate 20, Sodium Benzoate, Water

  • PURPOSE

    Decrease bacteria on skin. For use when soap and water are not available.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    ■ Discard after single use and do not flush in the toilet.

    ■ Reseal back after use to avoid evaporation of alcohol

    ■ Supervise children under 6 years of age when using this product to avoid swallowing.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    ■ in children less than 2 months of age.

    ■ on open skin wounds.

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    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. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    GENTLE BEAST ANTISEPTIC WIPES 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75356-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75356-0008-1337 g in 1 PACKET; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2021
    Labeler - AJ Co., Ltd. (631079605)
    Registrant - AJ Co., Ltd. (631079605)
    Establishment
    NameAddressID/FEIBusiness Operations
    AJ Co., Ltd.631079605manufacture(75356-0008) , label(75356-0008) , pack(75356-0008)
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