Label: ALCOHOL PREP PAD- alcohol swab

  • NDC Code(s): 59194-002-01
  • Packager: Zhejiang Changdi Medical 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 08/13

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  • Active Ingredient

    Isopropyl Alcohol 70%

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  • Purpose

    Antiseptic

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  • Use

    For preparation of skin prior to an injection 

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  • Warnning

    For External use only.

    Flammabel,keep away from fire or flame

    Do not use

    • with electrocautery procedures,
    • in the eyes,

    stop use if irritation and redness develop.

    Ask a doceor if condition persists for more than 72 hours

    Keep out of reach of children  except with adult supervision.

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

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  • Directions

    wipe injection site vigorously and discard

    Other informaiton store at room temperature

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  • Inactive Ingredients

    Inactive Ingredients: 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:59194-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 70 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    water 30 mL  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59194-002-01 24 in 1 CARTON
    1 100 in 1 BOX
    1 0.49 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 07/02/2013
    Labeler - Zhejiang Changdi Medical Co., Ltd. (528198683)
    Establishment
    Name Address ID/FEI Business Operations
    Zhejiang Changdi Medical Co., Ltd. 528198683 manufacture(59194-002)
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