FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
GDRG2, Inc.
Effective date
2020-04-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:10:20

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Indications and uses

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

Dosage and administration

Put enough product in palm to cover hands and rub hands together briskley until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store below 110F (43C) May discolor certain fabrics

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) (73%, 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 (1.00% v/v).
  3. Carbopol 940 (0.45% v/v).
  4. Triethanolamine (0.25% v/v).
  5. Sterile deionized 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

Ethyl Alcohol 73% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

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

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

Do not use

OTC - DO NOT USE SECTION

  • in or near the eyes

OTC - WHEN USING SECTION

When using this product do not use it in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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 appears and lasts.

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

  • Put enough product in palm to cover hands and rub hands together briskley until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F (43C)
  • May discolor certain fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Glycerol, Carbopol 940, Triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

29 mL NDC: 76999-7117-6
29 mL NDC: 76999-7117-629 mL NDC: 76999-7117-6

60 mL NDC: 76999-7094-5
60 mL NDC: 76999-7094-560 mL NDC: 76999-7094-5


250 mL NDC: 76999-7056-3
250 mL NDC: 76999-7056-3250 mL NDC: 76999-7056-3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76999-7056-32022-01-28C16284748780-1d6a99b39-7104-a426-e053-dadaa90af4c2a462eb01-54f6-1028-e053-2a95a90a6aac
76999-7117-62022-01-28C16284748780-1d6a99b39-7104-a426-e053-dadaa90af4c2a462eb01-54f6-1028-e053-2a95a90a6aac
76999-7131-52022-01-28C16284748780-1d6a99b39-7104-a426-e053-dadaa90af4c2a462eb01-54f6-1028-e053-2a95a90a6aac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76999-7056-3Hand Sanitizer250 mL in 1 BOTTLEGEL2501
76999-7117-6Hand Sanitizer29 mL in 1 BOTTLEGEL291
76999-7131-5Hand Sanitizer60 mL in 1 BOTTLEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76999-7056HAND SANITIZER (SANITIZER GEL) GEL [GDRG2, INC.]1Legacy NDC, 1 package rows20200509_a462eb01-54f6-1028-e053-2a95a90a6aac.zip
76999-7117HAND SANITIZER (SANITIZER GEL) GEL [GDRG2, INC.]1Legacy NDC, 1 package rows20200509_a462eb01-54f6-1028-e053-2a95a90a6aac.zip
76999-7131HAND SANITIZER (SANITIZER GEL) GEL [GDRG2, INC.]1Legacy NDC, 1 package rows20200509_a462eb01-54f6-1028-e053-2a95a90a6aac.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
76999-713176999-7131-5
56084-001
76999-705676999-7056-3
56084-005
76999-711776999-7117-6
56084-003

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
CUPRIC BIS(TRIETHANOLAMINE)YBM44X0B6HIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
CUPRIC BIS(TRIETHANOLAMINE)YBM44X0B6HIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
CUPRIC BIS(TRIETHANOLAMINE)YBM44X0B6HIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT

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
a4627d74-41c1-2be8-e053-2995a90ae101a462eb01-54f6-1028-e053-2a95a90a6aac2020-04-28WarningsExact identifier
spl id: a4627d74-41c1-2be8-e053-2995a90ae101
spl set id: a462eb01-54f6-1028-e053-2a95a90a6aac

Reported adverse events (FAERS/openFDA)#

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