83535-003-01 - DailyMed Details

83535-003-01

SPL v1

SPL

SPL Set ID ff53d3ab-39b6-8f54-e053-6294a90ac6ab

Route

topical

Published

Effective Date 2023-06-30

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 not final active Since 2023-06-30

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Uses

●Hand sanitizer to help reduce bacteria

●For use when soap and water are not available.

Purpose

Antibacterial

Directions

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

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

Inactive Ingredients

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

Description

Benzalkonium Chloride 0.13%

Question?

Call 718-975-2586

Do Not Use

●in children less than 2 months old.

●on open skin wounds

Package Label

Active Ingredient

Benzalkonium Chloride 0.13%

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

Warnings

For external use only.

Uses

●Hand sanitizer to help reduce bacteria

●For use when soap and water are not available.

Purpose

Antibacterial

Directions

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

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

Inactive Ingredients (Inactive ingredients)

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

Question?

Call 718-975-2586

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 0.13%

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": ".ALPHA.-TOCOPHEROL, DL-", "unii": "7QWA1RIO01", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "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": "0.13", "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 0.13%", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:58.441719 · Updated: 2026-03-14T23:01:14.422395