FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Oxygen Development LLC
Effective date
2021-02-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:51:33

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin.

Dosage and administration

Place enough product in your palm to thoroughly cover your hands Rub hands together until dry Recommended for repeated use Children under 6 years should be supervised when using this product

Storage and handling

Store at a temperature below 110F (43C) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from sources of heat, fire or flame.
For external use only.

Warnings

OTC - WHEN USING SECTION

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

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops and lasts.

Warnings

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product in your palm to thoroughly cover your hands
Rub hands together until dry
Recommended for repeated use
Children under 6 years should be supervised when using this product

Other information

STORAGE AND HANDLING SECTION

Store at a temperature below 110F (43C)
May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aminomethyl Propanol, Carbomer, Methyl Gluceth-20

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473 mL NDC: 61354-022-01 61354-022-01_aw61354-022-01_aw

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-022-012023-02-15C16284748780-1f386c64a-3bbd-0266-e053-dadaa90a7c1aGoodwill Labs Advanced Hand Sanitizer
61354-022-012023-01-30C16284748780-1f386c64a-3bbd-0266-e053-dadaa90a7c1aGoodwill Labs Advanced Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-02261354-022-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL GLUCETH-20J3QD0LD11PIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT

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
f45d92db-3df2-af4d-e053-2995a90a5cb4bba19d60-5752-4cad-e053-2995a90ad5542023-02-10WarningsExact identifier
spl set id: bba19d60-5752-4cad-e053-2995a90ad554

Reported adverse events (FAERS/openFDA)#

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