biopure antibacterial hand wipe

SPL v5

SPL

SPL Set ID 17b907cf-ae7d-49bd-9624-cd708dbb011e

Route

topical

Published

Effective Date 2022-12-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (1.3 mg)

Inactive Ingredients

aloe vera leaf .alpha.-tocopherol glycerin phenoxyethanol propylene glycol water

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 2023-01-15 Until 2023-12-31

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.

Other Information

Store in a cool, dry place.
Avoid freezing and excessive heat.

Inactive Ingredients

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

Description

Benzalkonium Chloride 0.13%

Questions?

call 718-975-2586

Drug Facts

78691 017 00

78691 017 01

Do Not Ues

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

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.

Other Information

Store in a cool, dry place.
Avoid freezing and excessive heat.

Inactive Ingredients (Inactive ingredients)

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

Questions?

call 718-975-2586

Drug Facts

78691 017 00 (78691-017-00)

78691 017 01 (78691-017-01)

Do Not Ues (Do not ues )

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

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": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "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": "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": "1.3", "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.", "Questions?": "call 718-975-2586", "Do not ues ": "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.", "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: 2026-02-15T12:06:44.496246 · Updated: 2026-03-14T23:09:41.311223