Label: ALCOHOL PREP PAD- isopropyl alcohol swab

  • 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 August 1, 2013

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  • Active Ingredient

    Isopropyl Alcohol 70%

  • Purpose

    Antiseptic

  • Use

    For preparation of skin prior to an injection 

  • 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.

  • Directions

    wipe injection site vigorously and discard

    Other informaiton store at room temperature

  • Inactive Ingredients

    Inactive Ingredients: Water

  • PRINCIPAL DISPLAY PANEL

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    label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59194-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R) 30 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59194-002-0124 in 1 CARTON
    1100 in 1 BOX
    10.49 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/02/2013
    Labeler - Zhejiang Changdi Medical Co., Ltd. (528198683)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Changdi Medical Co., Ltd.528198683manufacture(59194-002)
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