drug facts

drug facts

SPL v1

SPL

SPL Set ID 147ef8cf-6920-4812-9e42-8aeb01a239b6

Route

topical

Published

Effective Date 2020-04-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

benzalkonium (1.3 mg)

Inactive Ingredients

water hypromelloses edetate sodium citric acid monohydrate sodium hydroxide dmdm hydantoin

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-14

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Uses

to help reduce bacteria on the skin. For use when soap and water are not available.

Purpose

Antiseptic

Directions

put enough product in your palm to cover hands, rub hands together for at least 30 seconds. Allow to dry.
children under 6 years should be supervised when using this product.

Inactive Ingredients

Water (Aqua), Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Sodium Hydroxide, DMDM Hydantoin.

Description

Benzalkonium Chloride 0.13%

Label Copy

Do Not Use

on children less than 2 months of age
on open skin wounds

Active Ingredient

Benzalkonium Chloride 0.13%

Questions Or Comments?

1-866-695-3030

When Using This Product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If

irritation develops

Keep Out of Reach of Children.

If swallowed, call a Poison Control Center or get medical help right away.

Structured Label Content

Warnings

For external use only.

Uses

to help reduce bacteria on the skin. For use when soap and water are not available.

Purpose

Antiseptic

Directions

put enough product in your palm to cover hands, rub hands together for at least 30 seconds. Allow to dry.
children under 6 years should be supervised when using this product.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Sodium Hydroxide, DMDM Hydantoin.

Label Copy (Label copy)

Do Not Use (Do not use )

on children less than 2 months of age
on open skin wounds

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Questions Or Comments? (Questions or comments?)

1-866-695-3030

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

irritation develops

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

If swallowed, call a Poison Control Center or get medical help right away.

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE SODIUM", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "to help reduce bacteria on the skin. For use when soap and water are not available.", "Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "put enough product in your palm to cover hands, rub hands together for at least 30 seconds. Allow to dry. children under 6 years should be supervised when using this product.", "Do not use ": "on children less than 2 months of age on open skin wounds", "Active ingredient": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water (Aqua), Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Sodium Hydroxide, DMDM Hydantoin.", "Questions or comments?": "1-866-695-3030", "When using this product": "avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.", "Stop use and ask a doctor if": "irritation develops", "Keep out of reach of children.": "If swallowed, call a Poison Control Center or get medical help right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:13.587841 · Updated: 2026-03-14T22:56:12.801840