FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Tekkware, Inc. d.b.a. Gloucester Bio | Tekkware, Inc, d.b.a. Gloucester Bio
Effective date
2020-06-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:17:24

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

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

Dosage and administration

- Place enough product on hands to cover all surfaces. Rub hands together until dry. - Supervise children under six years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Alcohol (Ethyl Alcohol or Ethanol)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol

Hand Sanitizer

OTC - PURPOSE SECTION

OTC Antiseptic Drug Products

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, hydrogen peroxide, fragrance

Uses

INDICATIONS & USAGE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact 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 six years of age when using this product to avoid swallowing.

Warnings

WARNINGS SECTION

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

- Do not use in children less than 2 months of age. Do not use on open skin wounds.

- 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 occur. These may be signs of a serious condition.

473mL NDC: 74128-080-16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GB473GB473

473mL NDC: 74128-080-16

GBDrugFacts16ozGBDrugFacts16oz

GBDrugfacts16oz

3785mL NDC: 74128-080-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785mL NDC: 74128-080-01

GB3785GB3785

GBDrugFacts1gal

GBDrugFacts1galGBDrugFacts1gal

236mL NDC: 74128-070-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GB236GB236

236mL NDC: 74128-070-08

118mL NDC: 74128-070-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GB118GB118

118mL NDC: 74128-070-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN4
1241663ethanol 0.8 ML/ML Topical SpraySCD4
1241663ethanol 80 % Topical SpraySY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74128-070-042022-01-28C16284748780-1d6a99b39-4028-a426-e053-dadaa90af4c2a22ca66a-44e6-efcc-e053-2995a90a027c
74128-070-082022-01-28C16284748780-1d6a99b39-4028-a426-e053-dadaa90af4c2a22ca66a-44e6-efcc-e053-2995a90a027c
74128-080-012022-01-28C16284748780-1d6a99b39-4028-a426-e053-dadaa90af4c2a22ca66a-44e6-efcc-e053-2995a90a027c
74128-080-162022-01-28C16284748780-1d6a99b39-4028-a426-e053-dadaa90af4c2a22ca66a-44e6-efcc-e053-2995a90a027c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74128-070-04Hand Sanitizer118 mL in 1 BOTTLESPRAY1184
74128-070-08Hand Sanitizer236 mL in 1 BOTTLESPRAY2364
74128-080-01Hand Sanitizer3785 mL in 1 BOTTLESPRAY37854
74128-080-16Hand Sanitizer473 mL in 1 BOTTLESPRAY4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74128-070HAND SANITIZER (ETHYL ALCOHOL) SPRAY [TEKKWARE, INC. D.B.A. GLOUCESTER BIO]4Legacy NDC, 2 package rows20200613_a22ca66a-44e6-efcc-e053-2995a90a027c.zip
74128-080HAND SANITIZER (ETHYL ALCOHOL) SPRAY [TEKKWARE, INC. D.B.A. GLOUCESTER BIO]4Legacy NDC, 2 package rows20200613_a22ca66a-44e6-efcc-e053-2995a90a027c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74128-07074128-070-04, 74128-070-08
74128-08074128-080-16, 74128-080-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
LEMON OILI9GRO824LLIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
LEMON OILI9GRO824LLIACT

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
a7dcab72-e6b8-dc35-e053-2995a90a270aa22ca66a-44e6-efcc-e053-2995a90a027c2020-06-12WarningsExact identifier
spl id: a7dcab72-e6b8-dc35-e053-2995a90a270a
spl set id: a22ca66a-44e6-efcc-e053-2995a90a027c

Reported adverse events (FAERS/openFDA)#

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