83535-002

83535-002
SPL v2
SPL
SPL Set ID ff53d3ab-39b1-8f54-e053-6294a90ac6ab
Route
TOPICAL
Published
Effective Date 2024-04-03
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 2023-06-30
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 are 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

83535 002 01

83535 002 02

Active Ingredient

Benzalkonium Chloride 0.13%

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 are 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

83535 002 01 (83535-002-01)

83535 002 02 (83535-002-02)

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:55.762917 · Updated: 2026-03-14T23:02:45.179164