Label: ALCOHOL CLEANSING- 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 January 7, 2021

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  • DRUG FACTS

  • Active Ingredient:

    Isopropyl Alcohol, 70% v/v

    Purpose:

    Antiseptic

  • Use:

    For preparation of the skin before injection.

  • Warnings:

    For external use only.

    Flammable - keep away from fire or flame.

    Do not use:

    with electrocautery, in the eyes

    Stop use

    if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

    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.

  • Other information:

    Store at room temperature 15°-30° C (59°-86° F)

  • Inactive ingredient:

    Purified water.

  • Package Labeling:

    Alcohol cleansing

  • INGREDIENTS AND APPEARANCE
    ALCOHOL CLEANSING 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0012-020 in 1 KIT08/06/2016
    10.9 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/06/2016
    Labeler - CMC Group Inc. (117201448)
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