Label: 65 ETHYL ALCOHOL ANTISEPTIC HAND SANITIZER WIPES- 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 March 10, 2022

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 65%

    Purpose

    Antiseptic

  • Use

    for hand washing to decrease bacteria on the skin

  • Warnings

    For external use only

    Flammable, keep away from fire or flame.

    Do not use

    in the eyes

    Stop use and ask a doctor if

    • Irritation and redness develop
    • Condition persists for more than 72 hours

    Keep out of reach of children,

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

  • Directions:

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other Information

    • Store in a dry and cool place.
    • Keep away from direct sunlight.
    • Store below 110°F (43°C).
  • Inactive ingredients

    Purified water, propylene glycol, glycerin, isopropyl myristate, tocopheryl acetate, aloe vera, fragrance.

  • Questions?:

    +1-716-430-3572

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    65 ETHYL ALCOHOL ANTISEPTIC HAND SANITIZER WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82444-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82444-002-0025 in 1 BAG06/30/2022
    14 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/30/2022
    Labeler - SCHEVARAN LABORATORIES PRIVATE LIMITED (650656770)
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