HYGENIZE ORIGINAL HAND SANITIZER- isopropyl alcohol spray 
HYGENIZE ORIGINAL HAND SANITIZER- alcohol gel 
HYGENIZE ALCOHOL WIPES- alcohol patch 
Hygenize Corp.

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.

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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

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 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.

Directions

Other information

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

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)

Revised: 10/2020
Document Id: b1f9fe0c-7b44-d2d4-e053-2995a90aba65
Set id: b0cf6932-c303-5cf9-e053-2995a90a0c37
Version: 6
Effective Time: 20201018
 
Hygenize Corp.