Label: HYGENIZE ORIGINAL HAND SANITIZER- isopropyl alcohol spray
HYGENIZE ORIGINAL HAND SANITIZER- alcohol gel
HYGENIZE ALCOHOL WIPES- alcohol patch

  • NDC Code(s): 80808-001-04, 80808-001-94, 80808-002-02, 80808-002-04, view more
    80808-002-08, 80808-002-09, 80808-002-14, 80808-002-16, 80808-002-18, 80808-002-19, 80808-002-26, 80808-002-28, 80808-002-32, 80808-002-92, 80808-002-93, 80808-002-98, 80808-010-10, 80808-010-16, 80808-010-80, 80808-010-81, 80808-010-86, 80808-010-88, 80808-010-91, 80808-010-96, 80808-010-98
  • Packager: Hygenize Corp.
  • 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 18, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    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

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

  • STOP USE

    Stop use and ask a 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 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    160 1 NDC 8080801016

    946 ml NDC 8080800232

    60 ml NDC: 80808-002-02

    60ml NDC 808080202

    118 ml NDC: 80808-001-94

    118 ml NDC 8080800194

  • INGREDIENTS AND APPEARANCE
    HYGENIZE ORIGINAL HAND SANITIZER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80808-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80808-001-9448 in 1 CARTON10/04/2020
    1NDC:80808-001-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/04/2020
    HYGENIZE ORIGINAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80808-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80808-002-9248 in 1 CARTON10/04/2020
    1NDC:80808-002-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:80808-002-9312 in 1 CARTON10/04/2020
    2NDC:80808-002-32946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:80808-002-984 in 1 CARTON10/04/2020
    3NDC:80808-002-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:80808-002-1948 in 1 CARTON10/04/2020
    4NDC:80808-002-09237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    5NDC:80808-002-2632 in 1 CARTON10/04/2020
    5NDC:80808-002-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    6NDC:80808-002-1848 in 1 CARTON10/04/2020
    6NDC:80808-002-08237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    7NDC:80808-002-1448 in 1 CARTON10/04/2020
    7NDC:80808-002-04118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/04/2020
    HYGENIZE ALCOHOL WIPES 
    alcohol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80808-010
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80808-010-8112 in 1 CARTON10/04/2020
    1NDC:80808-010-91100 in 1 CANISTER
    1NDC:80808-010-105 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:80808-010-8612 in 1 CARTON10/04/2020
    2NDC:80808-010-96160 in 1 CANISTER
    2NDC:80808-010-165 mL in 1 PATCH; Type 0: Not a Combination Product
    3NDC:80808-010-9824 in 1 CARTON10/04/2020
    3NDC:80808-010-8880 in 1 CANISTER
    3NDC:80808-010-805 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 finalpart333E10/04/2020
    Labeler - Hygenize Corp. (089828811)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topicare Management079902303label(80808-002) , repack(80808-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cage080331158manufacture(80808-010)
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