Label: HS75- alcohol gel

  • NDC Code(s): 75512-008-01, 75512-008-02, 75512-008-03, 75512-008-04, view more
    75512-008-05
  • Packager: Integrity Bio-Chemicals, LLC
  • 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 June 25, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient[s]  Alcohol 75% v/v

  • PURPOSE

    Purpose Antiseptic

  • INDICATIONS & USAGE

    Use(s)
    Hand sanitizer to help reduce bacteria that potentially can cause
    disease. For use when soap and water are not available.

  • WARNINGS

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

  • DO NOT USE

    Do not use

    • On children less than 2 months of age

    • On open skin wounds

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case

    of contact with eyes, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation 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.

  • DOSAGE & ADMINISTRATION

    Directions
    • Place enough product on hands to cover all surfaces. Rub

       hands together until dry.

    • Supervise children under 6 years of age when using the

       product to avoid swallowing.

  • OTHER SAFETY INFORMATION

    Other information

    • Store between 15-30C (59-86F)

    • Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Inactive Ingredients: glycerin, *hydroxypropyl cellulose,

    *hydroxypropyl methylcellulose, water

    *May or may not include

  • Package Label - Principal Display Panel

    INTEGRITY

    BIOCHEM

    Hand Sanitizer

    HS75

    75% Alcohol

    3.79 L (1 US gal.)            Moisturizing Gel

            Manufactured by: INTEGRITY BIOCHEM

                    CRESSON, TX 76035

               www.integritybiochem.com

    MADE IN THE U.S.A. WITH PRIDE

    NDC: 75512-008-01                                        0  51497 17941  0

    008-01 1GAL

    res

  • INGREDIENTS AND APPEARANCE
    HS75 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75512-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75512-008-013.79 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2020
    2NDC:75512-008-0218.95 L in 1 PAIL; Type 0: Not a Combination Product05/20/2020
    3NDC:75512-008-03208.45 L in 1 DRUM; Type 0: Not a Combination Product05/20/2020
    4NDC:75512-008-041023.3 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product05/20/2020
    5NDC:75512-008-051231.75 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - Integrity Bio-Chemicals, LLC (080873668)
    Registrant - Integrity Bio-Chemicals, LLC (080873668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Integrity Bio-Chemicals, LLC080873668manufacture(75512-008)
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