Label: ALCOHOL PREP PAD- 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 October 6, 2018

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  • ACTIVE INGREDIENT

    image description

  • PURPOSE

    Antiseptic

  • Keep out of reach of children

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

  • USE

    For preparation of the skin prior to an injection

  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame.

  • DIRECTIONS

    Wipe injection site vigorously

  • INACTIVE INGREDIENT

    Water

  • DRUG FACTS

    image description

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54429-0101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54429-0101-11.4 mL in 1 POUCH; Type 0: Not a Combination Product12/26/2012
    2NDC:54429-0101-214 mL in 1 KIT; Type 0: Not a Combination Product12/26/2012
    3NDC:54429-0101-32.8 mL in 1 KIT; Type 0: Not a Combination Product12/26/2012
    4NDC:54429-0101-61.4 mL in 1 POUCH; Type 0: Not a Combination Product12/26/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/26/2012
    Labeler - Foshan Flying Medical Products Co., Ltd. (527021584)
    Registrant - Foshan Flying Medical Products Co., Ltd. (527021584)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Flying Medical Products Co., Ltd.527021584manufacture(54429-0101)
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