FDA.reportPublic FDA data

DuraFast Hand Sanitizer

Manufacturer
PRINTJET CORP | SUE SOTELO
Effective date
2020-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:25:08

Label at a glance#

ProductDuraFast Hand Sanitizer
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

237 ml NDC: 76795-750-04 76795-749-04 237 ml76795-749-04 237 ml

120 ml NDC: 76795-750-02 76795-749-02 120 ml76795-749-02 120 ml

8550 ml NDC: 76795-750-19 76795-749-19 8550 ml76795-749-19 8550 ml

950 ml NDC: 76795-750-05 76795-749-05 475 ml76795-749-05 475 ml

3785 ml NDC: 76795-750-07 76795-749-07 3785 ml76795-749-07 3785 ml

950 ml NDC: 76795-750-06 76795-749-06 950 ml76795-749-06 950 ml

60 ml NDC: 76795-750-01 76795-749- 01 60 ml76795-749- 01 60 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76795-750-012022-01-28C16284748780-1d6a99b39-c70f-a426-e053-dadaa90af4c2ad2e6fd9-63dd-59c8-e053-2995a90ae2ac
76795-750-022022-01-28C16284748780-1d6a99b39-c70f-a426-e053-dadaa90af4c2ad2e6fd9-63dd-59c8-e053-2995a90ae2ac
76795-750-042022-01-28C16284748780-1d6a99b39-c70f-a426-e053-dadaa90af4c2ad2e6fd9-63dd-59c8-e053-2995a90ae2ac
76795-750-052022-01-28C16284748780-1d6a99b39-c70f-a426-e053-dadaa90af4c2ad2e6fd9-63dd-59c8-e053-2995a90ae2ac
76795-750-062022-01-28C16284748780-1d6a99b39-c70f-a426-e053-dadaa90af4c2ad2e6fd9-63dd-59c8-e053-2995a90ae2ac
76795-750-072022-01-28C16284748780-1d6a99b39-c70f-a426-e053-dadaa90af4c2ad2e6fd9-63dd-59c8-e053-2995a90ae2ac
76795-750-192022-01-28C16284748780-1d6a99b39-c70f-a426-e053-dadaa90af4c2ad2e6fd9-63dd-59c8-e053-2995a90ae2ac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76795-750-01DuraFast Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL603
76795-750-02DuraFast Hand Sanitizer120 mL in 1 BOTTLE, PLASTICGEL1203
76795-750-04DuraFast Hand Sanitizer237 mL in 1 BOTTLE, PLASTICGEL2373
76795-750-05DuraFast Hand Sanitizer475 mL in 1 BOTTLE, PLASTICGEL4753
76795-750-06DuraFast Hand Sanitizer950 mL in 1 BOTTLE, PLASTICGEL9503
76795-750-07DuraFast Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37853
76795-750-19DuraFast Hand Sanitizer8550 mL in 1 BOTTLE, PLASTICGEL85503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76795-750DURAFAST HAND SANITIZER (ALCOHOL HAND SANITIZER) GEL [PRINTJET CORP]3Legacy NDC, 7 package rows20200819_ad2e6fd9-63dd-59c8-e053-2995a90ae2ac.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
76795-75076795-750-01, 76795-750-02, 76795-750-04, 76795-750-05, 76795-750-07, 76795-750-06, 76795-750-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
ad2e6fd9-63de-59c8-e053-2995a90ae2acad2e6fd9-63dd-59c8-e053-2995a90ae2ac2020-08-18WarningsExact identifier
spl id: ad2e6fd9-63de-59c8-e053-2995a90ae2ac
spl set id: ad2e6fd9-63dd-59c8-e053-2995a90ae2ac

Reported adverse events (FAERS/openFDA)#

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