Label: ALCOGENIX ANTISEPTIC HAND SANITIZER- alcohol solution

  • NDC Code(s): 90046-503-01
  • Packager: TANDUAY DISTILLERS INC.
  • 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 October 2, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient[s]

    Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Use [s]

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

    For use when soap and water are not available.

  • 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 keep out of eyes, ears and mouth.

    In case of contact with eyes, rinse thoroughly with water.

    Stop use and ask doctor if irritation or rash occurs.

    These may be signs of a serious condition.

    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 15-30C (59-86F)
    • Avoid freezing and excessive heat above (104F)
  • Inactive Ingredients

    glycerin, hydrogen peroxide, purified water USP

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    ABSOLUT DISTILLERS, INC.
    Malaruhatan, Lian, Batangas, Philippines

    Distributed by
    MIDWAY TRADING CORPORATION
    130 Battery Street, San Francisco, CA 94111

  • PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label

    ALCOGENIX™
    ALCOHOL ANTISEPTIC 80%

    TOPICAL SOLUTION
    HAND SANITIZER

    NON-STERILE SOLUTION
    Formulated consistent with the US Food and Drug Administration's
    & the World Health Organization's Guidelines

    1 GALLON (128 fl. oz. / 3.78 L)

    PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    ALCOGENIX ANTISEPTIC HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90046-503
    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:90046-503-013780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A10/01/2020
    Labeler - TANDUAY DISTILLERS INC. (718851876)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABSOLUT DISTILLERS, INC.718866569MANUFACTURE(90046-503)