FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
Tri-Chem Industries
Effective date
2020-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:06

Label at a glance#

ProductHand Sanitizer Gel
Active ingredientALCOHOL
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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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

Alcohol 80% 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

118 mL NDC: 74664-004-01

74664-004-0174664-004-01236 mL NDC: 74664-004-02

74664-004-0274664-004-02473 mL NDC: 74664-004-03

74664-004-0374664-004-0318.93 L NDC: 74664-004-04

74664-004-0474664-004-04

208 L NDC: 74664-004-05

74664-004-0574664-004-051040 L NDC: 74664-004-06

74664-004-0674664-004-061249 L NDC: 74664-004-07

74664-004-0774664-004-0724605 L NDC: 74664-004-08

74664-004-0874664-004-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74664-004-012022-01-28C16284748780-1d6a99b39-c3bb-a426-e053-dadaa90af4c2a8da61d4-bf50-258b-e053-2a95a90ab80d
74664-004-022022-01-28C16284748780-1d6a99b39-c3bb-a426-e053-dadaa90af4c2a8da61d4-bf50-258b-e053-2a95a90ab80d
74664-004-032022-01-28C16284748780-1d6a99b39-c3bb-a426-e053-dadaa90af4c2a8da61d4-bf50-258b-e053-2a95a90ab80d
74664-004-042022-01-28C16284748780-1d6a99b39-c3bb-a426-e053-dadaa90af4c2a8da61d4-bf50-258b-e053-2a95a90ab80d
74664-004-052022-01-28C16284748780-1d6a99b39-c3bb-a426-e053-dadaa90af4c2a8da61d4-bf50-258b-e053-2a95a90ab80d
74664-004-062022-01-28C16284748780-1d6a99b39-c3bb-a426-e053-dadaa90af4c2a8da61d4-bf50-258b-e053-2a95a90ab80d
74664-004-072022-01-28C16284748780-1d6a99b39-c3bb-a426-e053-dadaa90af4c2a8da61d4-bf50-258b-e053-2a95a90ab80d
74664-004-082022-01-28C16284748780-1d6a99b39-c3bb-a426-e053-dadaa90af4c2a8da61d4-bf50-258b-e053-2a95a90ab80d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74664-004-01Hand Sanitizer Gel118 mL in 1 BOTTLEGEL1181
74664-004-02Hand Sanitizer Gel236 mL in 1 BOTTLEGEL2361
74664-004-03Hand Sanitizer Gel473 mL in 1 BOTTLEGEL4731
74664-004-04Hand Sanitizer Gel18930 mL in 1 BOTTLEGEL189301
74664-004-05Hand Sanitizer Gel208000 mL in 1 DRUMGEL2080001
74664-004-06Hand Sanitizer Gel1040000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10400001
74664-004-07Hand Sanitizer Gel1249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL12490001
74664-004-08Hand Sanitizer Gel24605000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL246050001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74664-004HAND SANITIZER GEL (ALCOHOL) GEL [TRI-CHEM INDUSTRIES]1Legacy NDC, 8 package rows20200626_a8da61d4-bf50-258b-e053-2a95a90ab80d.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74664-00474664-004-02, 74664-004-01, 74664-004-03, 74664-004-04, 74664-004-05, 74664-004-06, 74664-004-07, 74664-004-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT

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
a8da6480-bf13-7476-e053-2995a90a4c4ba8da61d4-bf50-258b-e053-2a95a90ab80d2020-06-24WarningsExact identifier
spl id: a8da6480-bf13-7476-e053-2995a90a4c4b
spl set id: a8da61d4-bf50-258b-e053-2a95a90ab80d

Reported adverse events (FAERS/openFDA)#

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