Label: ALCOHOL ANTISEPTIC 80% solution

  • 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 June 25, 2020

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  • ACTIVE INGREDIENT(S)

    Alcohol 80% v/v

  • PURPOSE

    Antiseptic

  • USE(S)

    Health care personnel hand rub to help reduce bacteria that potentially causes disease.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame.

  • DO NOT USE

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING THIS PRODUCT

    When using this product keep out of eyes, ears, and mouth. In case  of contact with eyes, rinse thoroughly with water.

  • STOP USE AND ASK DOCTOR IF

    Stop using and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing
  • OTHER INFORMATION

    • Store between 15-30oC (59-86oF)
    • Avoid freezing and excessive heat above 40oC (104oF)
  • INACTIVE INGREDIENT SECTION

    glycerin, hydrogen peroxide, purified water USP

  • QUESTIONS OR COMMENTS

    Call 1-855-274-4122

  • PRINCIPAL DISPLAY PANEL

    AUROHEALTH
    NDC 58602-004-38
    Alcohol Aniseptic 80%
    Topical Solution
    Antiseptic Hand Rub
    Non-sterile Solution
    128 OZ (3785 mL)


    alcohol
  • INGREDIENTS AND APPEARANCE
    ALCOHOL ANTISEPTIC 80% 
    alcohol antiseptic 80% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-004-383785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A06/25/2020
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolife Pharma LLC080970299ANALYSIS(58602-004) , RELABEL(58602-004) , REPACK(58602-004) , LABEL(58602-004) , MANUFACTURE(58602-004) , PACK(58602-004)
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