FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Fifth Generation, Inc.
Effective date
2020-08-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:18:56

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethanol 80% v/v

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

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.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • 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 SAFETY INFORMATION

Other Information:

Store between 15-30c (59-86F)

Avoid freezing and excessive heat above 40 C (104F)

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 mL 73982-000-01

100 mL 73982-000-00

375 mL 73982-000-02

3785 mL 73982-000-03

11356mL 73982-000-04

18927 mL 73982-000-05

208197 mL 73982-000-06

Package Front LabelPackage Front LabelPackage Back LabelPackage Back Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73982-000-002025-01-09C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-012025-01-09C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-022025-01-09C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-032025-01-09C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-042025-01-09C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-052025-01-09C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-062025-01-09C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-072025-01-09C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-002022-01-28C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-012022-01-28C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-022022-01-28C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-032022-01-28C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-042022-01-28C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-052022-01-28C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-062022-01-28C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer
73982-000-072022-01-28C16284748780-1d6a99b39-5e98-a426-e053-dadaa90af4c2Hand sanitizer

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
73982-00073982-000-01, 73982-000-00, 73982-000-02, 73982-000-03, 73982-000-04, 73982-000-05, 73982-000-06, 73982-000-07

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
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
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
2b49e7a7-5c77-07e5-e063-6294a90a96f1a1daad10-f217-2254-e053-2995a90abaa92025-01-09WarningsExact identifier
spl set id: a1daad10-f217-2254-e053-2995a90abaa9

Reported adverse events (FAERS/openFDA)#

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