foaming hand sanitizer refill (fragrance free)

SPL v1

SPL

SPL Set ID 2be1480c-75bf-4bd6-9800-4f01f9d6c88a

Route

topical

Published

Effective Date 2021-02-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (1.3 mg)

Inactive Ingredients

citric acid monohydrate hydroxypropyl bis-hydroxyethyldimonium chloride water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2021-02-01

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only, do not use in ears, mouth, or eyes.

Uses

• hand sanitizer that helps decrease bacteria on the skin

• recommend for repeated use

Purpose

Antimicrobial

Directions

• pour liquid into a foaming dispenser

• pump a small amount of foam into palm of hand

• spread thoroughly on both hands

• rub hands together until dry

Inactive Ingredients

Citric Acid, Dimonium Chloride Cocoamidopropyl Hydroxysultaine, Hydroxypropyl Bis-Hydroxyethyldimonium Chloride, Rose Ether, Water.

Description

Benzalkonium Chloride 0.13%

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Package Labeling: 473ml

Package Labeling: 946ml

When Using This Product

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use and Ask A Doctor

if irritation or redness develops, or if condition persists for more than 72 hours.

Keep Out of Reach of Children

Children should be supervised when using this product.

Structured Label Content

Warnings

For external use only, do not use in ears, mouth, or eyes.

Uses

• hand sanitizer that helps decrease bacteria on the skin

• recommend for repeated use

Purpose

Antimicrobial

Directions

• pour liquid into a foaming dispenser

• pump a small amount of foam into palm of hand

• spread thoroughly on both hands

• rub hands together until dry

Inactive Ingredients

Citric Acid, Dimonium Chloride Cocoamidopropyl Hydroxysultaine, Hydroxypropyl Bis-Hydroxyethyldimonium Chloride, Rose Ether, Water.

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Package Labeling: 473ml

Package Labeling: 946ml

When Using This Product (When using this product)

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation or redness develops, or if condition persists for more than 72 hours.

Keep Out of Reach of Children (Keep out of reach of children)

Children should be supervised when using this product.

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE", "unii": "1EO3O1X7HG", "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 that helps decrease bacteria on the skin • recommend for repeated use", "Purpose": "Antimicrobial", "Warnings": "For external use only, do not use in ears, mouth, or eyes.", "Directions": "• pour liquid into a foaming dispenser • pump a small amount of foam into palm of hand • spread thoroughly on both hands • rub hands together until dry", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Inactive Ingredients": "Citric Acid, Dimonium Chloride Cocoamidopropyl Hydroxysultaine, Hydroxypropyl Bis-Hydroxyethyldimonium Chloride, Rose Ether, Water.", "When using this product": "avoid contact with eyes. In case of eye contact, flush eyes with water.", "Stop use and ask a doctor": "if irritation or redness develops, or if condition persists for more than 72 hours.", "Keep out of reach of children": "Children should be supervised when using this product."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:22.330158 · Updated: 2026-03-14T22:59:19.689823