biopure antibacterial hand wipes benzalkonium chloride 0.12% - 250 wipes

SPL v5

SPL

SPL Set ID ae2fdb32-05c6-6d16-e053-2995a90a552d

Route

topical

Published

Effective Date 2025-12-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (1.2 mg)

Inactive Ingredients

glycerin phenoxyethanol propylene glycol water

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2020-09-20

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.12%

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.

Other Information

• Store in a cool, dry place, between 15°-30° (59°-86°F). • Avoid freezing and excessive heat above 40°C (104°F).

Inactive Ingredients

Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

Description

Benzalkonium Chloride 0.12%

Questions?

call 718-975-2586

Do Not Use

• in children less than 2 months old. • on open skin wounds.

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.12%

Package Labeling:

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.

Other Information (Other information)

• Store in a cool, dry place, between 15°-30° (59°-86°F). • Avoid freezing and excessive heat above 40°C (104°F).

Inactive Ingredients (Inactive ingredients)

Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

Questions?

call 718-975-2586

Do Not Use (Do not use)

• in children less than 2 months old. • on open skin wounds.

Drug Facts

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.12%

Package Labeling:

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 If (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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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.", "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.", "Questions?": "call 718-975-2586", "Active ingredient": "Benzalkonium Chloride 0.12%", "Other information": "• Store in a cool, dry place, between 15°-30° (59°-86°F). • Avoid freezing and excessive heat above 40°C (104°F).", "Inactive ingredients": "Glycerin, Phenoxyethanol, Propylene Glycol, Purified 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: 2026-02-15T12:08:01.337664 · Updated: 2026-03-14T23:12:10.193103