Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 6aa2fc38-c077-4b96-81f1-c6c18db56cbf

Route

TOPICAL

Published

Effective Date 2020-10-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzalkonium (0.13 1)

Inactive Ingredients

Water Polysorbate 20 Edetate Disodium Anhydrous Phenoxyethanol Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-10-05

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Use

Antiseptic cleanser, helps decrease bacteria on skin.

Warnings

For external use only.

Directions

Lift tab and pull out towel to wipe hands thoroughly for 30 seconds. Allow to air dry.
Reseal after use to prevent moisture from evaporating.
Children under 6 years of age should be supervised when using this product.

Label Copy

Questions?

Call 1-800-548-4097

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Store at room temperature.

Inactive Ingredients

Water (Aqua), Polysorbate 20, Disodium EDTA, Phenoxyethanol, Sodium Hydroxide.

When Using This Product

Avoid contact with the eyes; in case of contact, flush eyes with water.

Stop Use and Ask A Doctor If

irritation or redness develops and persists

Keep Out of Reach of Children.

If injested, get medical help or contact a Poison Control Center right away

Structured Label Content

Use

Antiseptic cleanser, helps decrease bacteria on skin.

Purpose

Antiseptic

Warnings

For external use only.

Directions

Lift tab and pull out towel to wipe hands thoroughly for 30 seconds. Allow to air dry.
Reseal after use to prevent moisture from evaporating.
Children under 6 years of age should be supervised when using this product.

Label Copy (Label copy)

Questions?

Call 1-800-548-4097

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information (Other information)

Store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Polysorbate 20, Disodium EDTA, Phenoxyethanol, Sodium Hydroxide.

When Using This Product (When using this product)

Avoid contact with the eyes; in case of contact, flush eyes with water.

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

irritation or redness develops and persists

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

If injested, get medical help or contact a Poison Control Center right away

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "1", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Antiseptic cleanser, helps decrease bacteria on skin.", "Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "Lift tab and pull out towel to wipe hands thoroughly for 30 seconds. Allow to air dry. Reseal after use to prevent moisture from evaporating. Children under 6 years of age should be supervised when using this product.", "Questions?": "Call 1-800-548-4097", "Active ingredient": "Benzalkonium Chloride 0.13%", "Other information": "Store at room temperature.", "Inactive ingredients": "Water (Aqua), Polysorbate 20, Disodium EDTA, Phenoxyethanol, Sodium Hydroxide.", "When using this product": "Avoid contact with the eyes; in case of contact, flush eyes with water.", "Stop use and ask a doctor if": "irritation or redness develops and persists", "Keep out of reach of children.": "If injested, get medical help or contact a Poison Control Center right away"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:51.507084 · Updated: 2026-03-14T22:58:38.353182