Label: ALCOHOL PREP PAD- isopropyl alcohol swab

  • NDC Code(s): 43128-050-01, 43128-050-02
  • Packager: NDC National Distribution & Contracting, Inc.
  • 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 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Isopropyl Alcohol 70%

  • Purpose

    Antiseptic Cleanser

  • Use

    For Preparation of Skin prior to an injection

  • WARNINGS

    Warnings

    • For External Use Only
    • Flammable, Keep away from fire or flame
  • DO NOT USE

    Do Not Use

    • with electrocautery procedures
    • In the Eyes. If contact occurs, flush eyes with water
  • STOP USE

    Stop Use

    If irritation and redness develop. If condition persists, consult your health care practitioner.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • Directions

    Wipe injection site vigorously and discard.

  • STORAGE AND HANDLING

    Other Information

    Store at Room Temperature 15 - 30 C (59 - 86 F)

  • INACTIVE INGREDIENT

    Inactive Ingredient

    purified water

  • PRINCIPAL DISPLAY PANEL - 100 Pouch Box Label

    REF: P902050

    Sterile

    Alcohol
    Prep Pads

    Large (1.75 IN × 3.5 IN)

    For Professional and Hospital Use

    Sterile unless package is opened or damaged.
    Do not resterilize.

    Pro
    Advantage     ®
    by NDC

    10 boxes/case | 100/box

    PRINCIPAL DISPLAY PANEL - 100 Pouch Box Label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43128-050
    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:43128-050-01100 in 1 BOX12/15/2011
    11 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:43128-050-02200 in 1 BOX12/15/2011
    21 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/15/2011
    Labeler - NDC National Distribution & Contracting, Inc. (009831413)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dukal421317073manufacture(43128-050)
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