FDA.reportPublic FDA data

Hygenize Original Hand Sanitizer

Manufacturer
Hygenize Corp. | Topicare Management | Cage
Effective date
2020-10-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:31:56

Label at a glance#

ProductHygenize Original Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL, ALCOHOL
Label structure13 sections

Dosage and administration

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.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

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)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160 1 NDC 8080801016160 1 NDC 8080801016

946 ml NDC 8080800232946 ml NDC 8080800232

60 ml NDC: 80808-002-02

60ml NDC 80808020260ml NDC 808080202

118 ml NDC: 80808-001-94

118 ml NDC 8080800194118 ml NDC 8080800194

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1598066isopropyl alcohol 75 % Topical SprayPSN6
1598066isopropyl alcohol 0.75 ML/ML Topical SpraySCD6
1598066isopropyl alcohol 75 % Topical SpraySY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80808-001-04Hygenize Original Hand Sanitizer118 mL in 1 BOTTLE, SPRAYSPRAY1186
80808-001-94Hygenize Original Hand Sanitizer48 in 1 CARTONSPRAY486
80808-002-02Hygenize Original Hand Sanitizer60 mL in 1 BOTTLE, DISPENSINGGEL606
80808-002-04Hygenize Original Hand Sanitizer118 mL in 1 BOTTLE, DISPENSINGGEL1186
80808-002-08Hygenize Original Hand Sanitizer237 mL in 1 BOTTLE, DISPENSINGGEL2376
80808-002-09Hygenize Original Hand Sanitizer237 mL in 1 BOTTLE, PUMPGEL2376
80808-002-14Hygenize Original Hand Sanitizer48 in 1 CARTONGEL486
80808-002-16Hygenize Original Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5006
80808-002-18Hygenize Original Hand Sanitizer48 in 1 CARTONGEL486
80808-002-19Hygenize Original Hand Sanitizer48 in 1 CARTONGEL486
80808-002-26Hygenize Original Hand Sanitizer32 in 1 CARTONGEL326
80808-002-28Hygenize Original Hand Sanitizer3785 mL in 1 BOTTLEGEL37856
80808-002-32Hygenize Original Hand Sanitizer946 mL in 1 BOTTLE, PUMPGEL9466
80808-002-92Hygenize Original Hand Sanitizer48 in 1 CARTONGEL486
80808-002-93Hygenize Original Hand Sanitizer12 in 1 CARTONGEL126
80808-002-98Hygenize Original Hand Sanitizer4 in 1 CARTONGEL46
80808-010-10Hygenize Alcohol Wipes5 mL in 1 PATCHPATCH56
80808-010-16Hygenize Alcohol Wipes5 mL in 1 PATCHPATCH56
80808-010-80Hygenize Alcohol Wipes5 mL in 1 PATCHPATCH56
80808-010-81Hygenize Alcohol Wipes12 in 1 CARTONPATCH126
80808-010-86Hygenize Alcohol Wipes12 in 1 CARTONPATCH126
80808-010-88Hygenize Alcohol Wipes80 in 1 CANISTERPATCH806
80808-010-91Hygenize Alcohol Wipes100 in 1 CANISTERPATCH1006
80808-010-96Hygenize Alcohol Wipes160 in 1 CANISTERPATCH1606
80808-010-98Hygenize Alcohol Wipes24 in 1 CARTONPATCH246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80808-001HYGENIZE ORIGINAL HAND SANITIZER (ISOPROPYL ALCOHOL) SPRAY HYGENIZE ORIGINAL HAND SANITIZER (ALCOHOL) GEL HYGENIZE ALCOHOL WIPES (ALCOHOL) PATCH [HYGENIZE CORP.]6Legacy NDC, 2 package rows20201019_b0cf6932-c303-5cf9-e053-2995a90a0c37.zip
80808-002HYGENIZE ORIGINAL HAND SANITIZER (ISOPROPYL ALCOHOL) SPRAY HYGENIZE ORIGINAL HAND SANITIZER (ALCOHOL) GEL HYGENIZE ALCOHOL WIPES (ALCOHOL) PATCH [HYGENIZE CORP.]6Legacy NDC, 14 package rows20201019_b0cf6932-c303-5cf9-e053-2995a90a0c37.zip
80808-010HYGENIZE ORIGINAL HAND SANITIZER (ISOPROPYL ALCOHOL) SPRAY HYGENIZE ORIGINAL HAND SANITIZER (ALCOHOL) GEL HYGENIZE ALCOHOL WIPES (ALCOHOL) PATCH [HYGENIZE CORP.]6Legacy NDC, 9 package rows20201019_b0cf6932-c303-5cf9-e053-2995a90a0c37.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80808-00280808-002-02, 80808-002-92, 80808-002-32, 80808-002-93, 80808-002-28, 80808-002-98, 80808-002-09, 80808-002-19, 80808-002-16, 80808-002-26, 80808-002-08, 80808-002-18, 80808-002-04, 80808-002-14
80808-01080808-010-10, 80808-010-91, 80808-010-81, 80808-010-16, 80808-010-96, 80808-010-86, 80808-010-80, 80808-010-88, 80808-010-98
80808-00180808-001-04, 80808-001-94

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b1f9fe0c-7b44-d2d4-e053-2995a90aba65b0cf6932-c303-5cf9-e053-2995a90a0c372020-10-18WarningsExact identifier
spl id: b1f9fe0c-7b44-d2d4-e053-2995a90aba65
spl set id: b0cf6932-c303-5cf9-e053-2995a90a0c37

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.