Label: ALCOHOL PREP PAD- isopropyl alcohol cloth

  • 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 November 9, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Isopropyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use

    for preparation of the skin prior to an injection.

  • Warnings

    For external use only. Flammable, keep away from fire or flame. Do not use with electrocautery procedures or near eyes. Stop use and ask a doctor if irritation or redness develops.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Apply topically as needed to clean intended area. Discard after single use.

  • Inactive Ingredients

    purified water

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    ASP Global, LLC
    7800 Third Flag Parkway,
    Austell, GA 30168, USA

  • PRINCIPAL DISPLAY PANEL - 1 Pad Pouch Label

    ASP
    MEDICAL
    NDC 59448-005-01

    ALCOHOL PREP PAD

    2 Ply • Large

    STERILE R
    Single Use
    Not Made With
    Natural Rubber Latex

    Saturated with 70% v/v Isopropyl Alcohol

    Sterility guaranteed unless package is opened
    or damaged.

    I EA

    REORDER #
    PPA030

    www.aspglobal.com

    Principal Display Panel - 1 Pad Pouch Label
  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-005-010.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)07/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E07/21/2020
    Labeler - ASP Global, LLc (080361159)
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