Hand Sanitizer

Manufacturer
Oxygen Development LLC
Effective date
2022-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:27

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

Alcohol 70%

Purpose

Antiseptic

Uses

Use

For handwashing to decrease bacteria on the skin

Warnings

Warnings

Do not eat or drink. Topical application only. Flammable. Keep away from fire or flame. For external use only. When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Directions And Dosage

Directions

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

Other Label Information

Inactive ingredient

Water/Aqua, Glycerin, Fragrance, Polysorbate 20, Carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice

Package Label

Label Images#

SLHS05795_Hibiscus Fruit Punch Label_Page_1
SLHS05795_Hibiscus Fruit Punch Label_Page_1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-077-012025-01-30C16284748780-12cef2736-5cbf-d83d-e063-dadaa90ab31fGel Hand Sanitizer with aloe Moisturizes & Hydrates Skin 70% Alcohol. Hibiscus Fruit Punch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-077-01Hand Sanitizer100 mL in 1 BOTTLELIQUID1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-077HAND SANITIZER (ALCOHOL) LIQUID [OXYGEN DEVELOPMENT LLC]1Legacy NDC, 1 package rows20220818_e660289d-e8ec-0bed-e053-2995a90a1514.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-07761354-077-01

Ingredients#

Complete SPL Sections#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

Do not eat or drink. Topical application only. Flammable. Keep away from fire or flame. For external use only. When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or rash persists

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 & rub together until dry. Children under 6 years of age should be supervised when using this product.

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredient

INACTIVE INGREDIENT SECTION

Water/Aqua, Glycerin, Fragrance, Polysorbate 20, Carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML