79794-800

79794-800
SPL v8
SPL
SPL Set ID ee484505-3bb1-2989-e053-2995a90aea2b
Route
TOPICAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Propylene Glycol .alpha.-tocopherol, Dl- Aloe Vera Leaf Glycerin Phenoxyethanol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-25

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

●Hand sanitizer to help reduce bacteria

●For use when soap and water not available.

Warnings

For external use only.

Question?

Call 718-975-2586

Directions

●Apply to hands, allow to air dry without wiping.



●Children under 6 years of age should be supervised when using this product

Do Not Use

●in children less than 2 months old.

●on open skin wounds

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

●Store in a cool, dry place.

●Avoid freezing and excessive heat.

Label 79794 800 01

Label 79794 800 02

Label 79794 800 07

Label 79794 800 08

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Label 79794 800 11

Label 79795 800 03

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Inactive Ingredients

Aloe Barbadensis Leaf Extract, Alpha-Tocopherol, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

When Using This Product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor

if irritation or rash occurs.

These may be signs of a serious condition

Keep Out of Reach of Children.

If swallowed. get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

●Hand sanitizer to help reduce bacteria

●For use when soap and water not available.

Purpose

Antibacterial

Warnings

For external use only.

Question?

Call 718-975-2586

Directions

●Apply to hands, allow to air dry without wiping.



●Children under 6 years of age should be supervised when using this product

Do Not Use (Do not use)

●in children less than 2 months old.

●on open skin wounds

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information

●Store in a cool, dry place.

●Avoid freezing and excessive heat.

Label 79794 800 01 (Label 79794-800-01)

Label 79794 800 02 (Label 79794-800-02)

Label 79794 800 07 (Label 79794-800-07)

Label 79794 800 08 (Label 79794-800-08)

Label 79794 800 09 (Label 79794-800-09)

Label 79794 800 10 (Label 79794-800-10)

Label 79794 800 11 (Label 79794-800-11)

Label 79795 800 03 (Label 79795-800-03)

Label 79795 800 04 (Label 79795-800-04)

Label 79795 800 05 (Label 79795-800-05)

Label 79795 800 06 (Label 79795-800-06)

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Alpha-Tocopherol, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

When Using This Product (When using this product)

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

if irritation or rash occurs.

These may be signs of a serious condition

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

If swallowed. get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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