FDA.reportPublic FDA data

GOLDEF ANTISEPTIC HAND SANITIZER

Manufacturer
MEDIPROMTECH, LLC
Effective date
2020-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:47

Label at a glance#

ProductGOLDEF ANTISEPTIC HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

• store between 15-30˚C (59-86˚F) • avoid freezing and excessive heat above 40˚C (104˚F) 

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame

For external use only

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

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if 

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

• store between 15-30˚C (59-86˚F) • avoid freezing and excessive heat above 40˚C (104˚F) 

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrogen peroxide, glycerin

Questions?

OTC - QUESTIONS SECTION

+1-404-795-4774

You may also report serious effectsto this phone number.

Mon-Fri 9:00AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 80%

Topical solution  Non-Sterile Solution

Moisturising

Manufactured by: MEDIPROMTECH LLC

Stelmaha 9, Irpin city, Ukraine 08205

COUNTRY OF ORIGIN: UKRAINE

info@goldef.ua

www.goldef.ua

Lot. No

Expiry

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackagingPackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79553-101-202022-01-28C16284748780-1d6a99b39-ded4-a426-e053-dadaa90af4c2GOLDEF ANTISEPTIC HAND SANITIZER
79553-101-302022-01-28C16284748780-1d6a99b39-ded4-a426-e053-dadaa90af4c2GOLDEF ANTISEPTIC HAND SANITIZER
79553-101-402022-01-28C16284748780-1d6a99b39-ded4-a426-e053-dadaa90af4c2GOLDEF ANTISEPTIC HAND SANITIZER
79553-101-502022-01-28C16284748780-1d6a99b39-ded4-a426-e053-dadaa90af4c2GOLDEF ANTISEPTIC HAND SANITIZER
79553-101-602022-01-28C16284748780-1d6a99b39-ded4-a426-e053-dadaa90af4c2GOLDEF ANTISEPTIC HAND SANITIZER
79553-101-702022-01-28C16284748780-1d6a99b39-ded4-a426-e053-dadaa90af4c2GOLDEF ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79553-101-20GOLDEF ANTISEPTIC HAND SANITIZER80 mL in 1 BOTTLE, SPRAYLIQUID801
79553-101-30GOLDEF ANTISEPTIC HAND SANITIZER100 mL in 1 BOTTLE, SPRAYLIQUID1001
79553-101-40GOLDEF ANTISEPTIC HAND SANITIZER250 mL in 1 BOTTLE, SPRAYLIQUID2501
79553-101-50GOLDEF ANTISEPTIC HAND SANITIZER500 mL in 1 BOTTLE, SPRAYLIQUID5001
79553-101-60GOLDEF ANTISEPTIC HAND SANITIZER1000 mL in 1 BOTTLE, SPRAYLIQUID10001
79553-101-70GOLDEF ANTISEPTIC HAND SANITIZER5000 mL in 1 CANISTERLIQUID50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79553-101GOLDEF ANTISEPTIC HAND SANITIZER (ALCOHOL) LIQUID [MEDIPROMTECH, LLC]1Legacy NDC, 6 package rows20200717_fc6ddeac-2c5f-444a-acdf-361372419598.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79553-10179553-101-20, 79553-101-30, 79553-101-40, 79553-101-50, 79553-101-60, 79553-101-70

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
GLYCERINPDC6A3C0OXIACT

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
ae6692b8-492f-4e85-88f2-017566f3468bfc6ddeac-2c5f-444a-acdf-3613724195982020-07-13WarningsExact identifier
spl id: ae6692b8-492f-4e85-88f2-017566f3468b
spl set id: fc6ddeac-2c5f-444a-acdf-361372419598

Reported adverse events (FAERS/openFDA)#

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