83535-008-01 - DailyMed Details

83535-008-01

SPL v1

SPL

SPL Set ID 0c4ddf78-052b-9a8b-e063-6394a90a8a1e

Route

TOPICAL

Published

Effective Date 2023-12-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.12 g)

Inactive Ingredients

Propylene Glycol Glycerin Phenoxyethanol Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-12-07

Description

Benzalkonium Chloride 0.12%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.12%

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

Package Label

Active Ingredient

Benzalkonium Chloride 0.12%

Other Information

●Store in a cool, dry place.

●Avoid freezing and excessive heat

Inactive Ingredients

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

Package Label (Package label)

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.12%

Other Information (Other information)

●Store in a cool, dry place.

●Avoid freezing and excessive heat

Inactive Ingredients (Inactive ingredients)

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

[{"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.12", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"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": "●in children less than 2 months old. ●on open skin wounds", "Active ingredient": "Benzalkonium Chloride 0.12%", "Other information": "●Store in a cool, dry place. ●Avoid freezing and excessive heat", "Inactive ingredients": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:29.427531 · Updated: 2026-03-14T23:02:04.460294