Label: ALCOHOL PREP- isopropyl alcohol cloth

  • 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 January 17, 2020

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  • Drug Facts

  • Active Ingredient

    Isopropyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • Antiseptic Cleanser
    • Kills harmful bacteria and germs
    • First Aid to Help Prevent Infection
  • Warnings

    • For External Use Only
    • Avoid contact with the eyes

    If contact occurs, flush eyes with water

    Flammable, keep away from flame or fire.

  • Do Not Use

    With electrocautery, in the eyes

  • Stop use and ask a doctor if

    Irritation and redness develops

    If condition persists for more than 72 hours, consult a physician

  • Keep out of reach of children

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

  • Directions

    Use as a part of your daily cleansing routine

    May be covered with a sterile bandage

  • Other Safety Information

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

    Avoid Excess Heat

  • Inactive Ingredients

    Water

  • PRINCIPAL DISPLAY PANEL

    u1-25.jpg

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68183-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 0.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68183-117-0110 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product10/19/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/15/2015
    Labeler - Custom Kits Company Inc (928643712)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Kits Company Inc928643712repack(68183-117) , relabel(68183-117)
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