Hand Sanitizer Gel with Fragrance

Manufacturer
Tri-Chem Industries
Effective date
2020-09-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:27

Label at a glance#

ProductHand Sanitizer Gel with Fragrance
Active ingredientISOPROPYL 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. Triethanolamine.
  5. Propylene glycol.
  6. Acrylic copolymer or carbomer.
  7. Fragrance.
  8. Sterile distilled water or boiled cold water.

The formulation meets the required efficacy for the protection of human health from germs and viruses when used in the absence of water and soap.

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, triethanolamine, propylene glycol, acrylic copolymer and/or carbomer, fragrance, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 mL NDC:74664-007-01 74664-007-0174664-007-01236 mL NDC: 74664-007-02 74664-007-0274664-007-02473 mL NDC: 74664-007-03 74664-007-0374664-007-0318900 mL NDC: 74664-007-04 74664-007-0474664-007-0420800 mL NDC: 74664-007-05 74664-007-0574664-007-051041000 mL NDC: 74664-007-06 74664-007-0674664-007-0612491000 mL NDC: 74664-007-07 74664-007-0774664-007-0724605000 mL NDC: 74664-007-08 74664-007-0874664-007-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN1
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD1
2285607isopropyl alcohol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74664-007-01Hand Sanitizer Gel with Fragrance118 mL in 1 BOTTLEGEL1181
74664-007-02Hand Sanitizer Gel with Fragrance236 mL in 1 BOTTLEGEL2361
74664-007-03Hand Sanitizer Gel with Fragrance18900 mL in 1 PAILGEL189001
74664-007-04Hand Sanitizer Gel with Fragrance20800 mL in 1 DRUMGEL208001
74664-007-05Hand Sanitizer Gel with Fragrance1041000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10410001
74664-007-06Hand Sanitizer Gel with Fragrance1249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL12490001
74664-007-07Hand Sanitizer Gel with Fragrance24605000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL246050001
74664-007-08Hand Sanitizer Gel with Fragrance473 mL in 1 BOTTLEGEL4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74664-007HAND SANITIZER GEL WITH FRAGRANCE (ISOPROPYL ALCOHOL) GEL [TRI-CHEM INDUSTRIES]1Legacy NDC, 8 package rows20201013_affbbd57-674b-1ef3-e053-2995a90aa99e.zip

Products#

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NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
affbbd57-673d-1ef3-e053-2995a90aa99eaffbbd57-674b-1ef3-e053-2995a90aa99e2020-09-23WarningsExact identifier
spl id: affbbd57-673d-1ef3-e053-2995a90aa99e
spl set id: affbbd57-674b-1ef3-e053-2995a90aa99e

Reported adverse events (FAERS/openFDA)#

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