SPL v1
SPL
SPL Set ID 336c751f-6a33-ca55-e063-6394a90a9749
Route
TOPICAL
Published
Effective Date 2025-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.005 mL)
Inactive Ingredients
Aminomethylpropanol Aqua Alpha-tocopherol Acetate Fd&c Yellow No. 6 Fd&c Red No. 40 Plum Glycerin Aloe Barbadensis Leaf Juice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-23

Description

Spray onto hands and rub together until dry. Recommended for repeat use.Children under 6 years of age should be supervised when using this product


Medication Information

Description

Spray onto hands and rub together until dry. Recommended for repeat use.Children under 6 years of age should be supervised when using this product

Use

Hand sanitizer helps reduce bacteria and the spread of germs.

Section 51945-4

Warnings:

For external use only. Flammable, keep away from fire or flame.

Directions:

Spray onto hands and rub together until dry. Recommended for repeat use.Children under 6 years of age should be supervised when using this product

Active Ingredients:

Ethyl Alcohol 70% v/v Purpose:Antimicrobial

Inactive Ingredients:

Water(Aqua), Glycerin,Aminomethyl Propanol,Fragrance,Aloe Barbadensis Leaf Juice,Tocopheryl Acetate(Vitamin E),Yellow 6,Red 40.

When Using This Product:

In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin.

Stop Use and Ask A Doctor If:

lrritation and redness occurs.

Keep Out of Reach of Children:

lf swallowed, get medical help or contact a Poison Control Center.


Structured Label Content

Use (USE)

Hand sanitizer helps reduce bacteria and the spread of germs.

Section 51945-4 (51945-4)

Warnings:

For external use only. Flammable, keep away from fire or flame.

Directions:

Spray onto hands and rub together until dry. Recommended for repeat use.Children under 6 years of age should be supervised when using this product

Active Ingredients:

Ethyl Alcohol 70% v/v Purpose:Antimicrobial

Inactive Ingredients:

Water(Aqua), Glycerin,Aminomethyl Propanol,Fragrance,Aloe Barbadensis Leaf Juice,Tocopheryl Acetate(Vitamin E),Yellow 6,Red 40.

When Using This Product: (When using this product:)

In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

lrritation and redness occurs.

Keep Out of Reach of Children: (Keep out of reach of children:)

lf swallowed, get medical help or contact a Poison Control Center.


Advanced Ingredient Data


Raw Label Data

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