Label: ALCOHOL PREP PAD- isopropyl alcohol swab 

  • NDC Code(s): 54429-0101-1, 54429-0101-2, 54429-0101-3, 54429-0101-6
  • Packager: Foshan Flying Medical Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/14

If you are a consumer or patient please visit this version.

  • DRUG FACTS
  • ACTIVE INGREDIENT
  • PURPOSE

    Antiseptic

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  • Keep out of reach of children

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

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  • USE

    For preparation of the skin prior to an injection

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  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame.

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  • DIRECTIONS

    Wipe injection site vigorously

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  • INACTIVE INGREDIENT

    Water

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  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54429-0101
    Route of Administration Topical DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54429-0101-1 1.4 mL in 1 POUCH
    2 NDC:54429-0101-2 14 mL in 1 KIT
    3 NDC:54429-0101-3 2.8 mL in 1 KIT
    4 NDC:54429-0101-6 1.4 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/26/2012
    Labeler - Foshan Flying Medical Products Co., Ltd. (527021584)
    Registrant - Foshan Flying Medical Products Co., Ltd. (527021584)
    Establishment
    Name Address ID/FEI Business Operations
    Foshan Flying Medical Products Co., Ltd. 527021584 manufacture(54429-0101)
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