FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
AMERICAN RAVEN
Effective date
2024-11-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:39:48

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Keep away from Children Apply on the hands only

Label contents#

Full prescribing information#

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

  • Keep away from Children
  • Apply on the hands only

DOSAGE & ADMINISTRATION SECTION

  • Use hand sanitizer if you can't use soap and water.
  • Coat your palms and fingers.
  • Rub in thoroughly for 20 seconds.
  • Store in a cool, dry location.
  • Keep out of children's reach

WARNINGS SECTION

  • Store in a cool, dry location.
  • Keep out of children's reach.
  • Do not Ingest

INACTIVE INGREDIENT SECTION

  • Emollients (e.g., glycerin, Aloe Vera): help moisturize skin.
  • Polyacrylate (e.g., sodium polyacrylate): helps to thicken and stabilizes the ingredients.
  • Color
  • Fragrance: helps improve the scent.
  • Water: carrier ingredient for the other active and inactive ingredients

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children

OTC - PURPOSE SECTION

This product is intended to be used to disinfect the hands when soap and water are not available, and are left on and not rinsed off with water.

OTC - ACTIVE INGREDIENT SECTION

70% Ethyl alcohol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100ml picture - with hand.jpg100ml picture - with hand.jpgimage attached

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83029-200-022024-11-29C16284748780-11030e365-0520-111a-e063-dadaa90a10e2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83029-201-01Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL603
83029-201-02Hand Sanitizer1 in 1 BOXGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83029-201HAND SANITIZER GEL [AMERICAN RAVEN]32 package rows20241130_eb29a473-e669-3566-e053-2995a90a41e2.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83029-20183029-201-01, 83029-201-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
28095202-c02b-2a97-e063-6394a90a94f0eb29a473-e669-3566-e053-2995a90a41e22024-11-29WarningsExact identifier
spl id: 28095202-c02b-2a97-e063-6394a90a94f0
spl set id: eb29a473-e669-3566-e053-2995a90a41e2

Reported adverse events (FAERS/openFDA)#

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