FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Oxygen Development LLC
Effective date
2022-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:35

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store below 110F (43C) May discolor certain fabric surfaces.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

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

When using

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • Put enough product in your palm to cover hands and rub hands together until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F (43C)
  • May discolor certain fabric surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water / aqua, Glycerin, Carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-044-01_AW61354-044-01_AW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-044-012025-01-30C16284748780-12cef2736-a6b6-d83d-e063-dadaa90ab31fOxygen Health Wellness Hand Sanitizer infused with Aloe Vera 70% Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-044-01Hand Sanitizer100 mL in 1 BOTTLEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-044HAND SANITIZER (ALCOHOL) GEL [OXYGEN DEVELOPMENT LLC]1Legacy NDC, 1 package rows20220112_d551e722-8df4-d0b1-e053-2995a90a6c90.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
61354-04461354-044-01

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
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
d551e722-8de6-d0b1-e053-2995a90a6c90d551e722-8df4-d0b1-e053-2995a90a6c902022-01-11WarningsExact identifier
spl id: d551e722-8de6-d0b1-e053-2995a90a6c90
spl set id: d551e722-8df4-d0b1-e053-2995a90a6c90

Reported adverse events (FAERS/openFDA)#

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