FDA.reportPublic FDA data

Def+nse Antiseptic Hand Sanitizer Gel

Manufacturer
Lusty Libation Ltd.
Effective date
2020-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:23

Label at a glance#

ProductDefnse Antiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure11 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

Ethyl alcohol 70%

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

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

  • 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

denatonium benzoate, fragrance, glycerin, hydrogen peroxide, hydroxyethyl cellulose, water

Questions?

OTC - QUESTIONS SECTION

You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

HOLISTIC LIVING

NPN: 80099248

Manufactured by: Lusty Libation Inc. 620 Supertest Rd., Unit 5, Toronto, ON, Canada M3J 2M5

Product of Canada.

www.holisticlivingltd.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77846-888-022022-01-28C16284748780-1d6a99b39-78f1-a426-e053-dadaa90af4c2Def+nse Antiseptic Hand Sanitizer Gel
77846-888-042022-01-28C16284748780-1d6a99b39-78f1-a426-e053-dadaa90af4c2Def+nse Antiseptic Hand Sanitizer Gel
77846-888-082022-01-28C16284748780-1d6a99b39-78f1-a426-e053-dadaa90af4c2Def+nse Antiseptic Hand Sanitizer Gel
77846-888-102022-01-28C16284748780-1d6a99b39-78f1-a426-e053-dadaa90af4c2Def+nse Antiseptic Hand Sanitizer Gel
77846-888-162022-01-28C16284748780-1d6a99b39-78f1-a426-e053-dadaa90af4c2Def+nse Antiseptic Hand Sanitizer Gel
77846-888-402022-01-28C16284748780-1d6a99b39-78f1-a426-e053-dadaa90af4c2Def+nse Antiseptic Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77846-888-02Defnse Antiseptic Hand Sanitizer60 mL in 1 BOTTLEGEL601
77846-888-04Defnse Antiseptic Hand Sanitizer118 mL in 1 BOTTLEGEL1181
77846-888-08Defnse Antiseptic Hand Sanitizer237 mL in 1 BOTTLEGEL2371
77846-888-10Defnse Antiseptic Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
77846-888-16Defnse Antiseptic Hand Sanitizer500 mL in 1 BOTTLEGEL5001
77846-888-40Defnse Antiseptic Hand Sanitizer4000 mL in 1 BOTTLEGEL40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77846-888DEFNSE ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [LUSTY LIBATION LTD.]1Legacy NDC, 6 package rows20200811_b310f394-9efb-46c5-ac47-10430aaa711b.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77846-88877846-888-02, 77846-888-04, 77846-888-08, 77846-888-16, 77846-888-10, 77846-888-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
DENATONIUM BENZOATE4YK5Z54AT2IACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
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
56629b5a-e4ac-4df6-b081-dd47dcd3c6c2b310f394-9efb-46c5-ac47-10430aaa711b2020-07-28WarningsExact identifier
spl id: 56629b5a-e4ac-4df6-b081-dd47dcd3c6c2
spl set id: b310f394-9efb-46c5-ac47-10430aaa711b

Reported adverse events (FAERS/openFDA)#

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