50563-406/g1abhw08

SPL v1

SPL

SPL Set ID 9e526418-e4f0-4031-b63b-674c9a1860ab

Route

TOPICAL

Published

Effective Date 2020-10-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Cocamidopropyl Betaine Dmdm Hydantoin Disodium Hedta Citric Acid Monohydrate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-10-31

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

■ For hand washing to decrease bacteria on the skin

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Section 51945-4

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wound

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Directions

Apply a small amount to hands, lather, then rinse with warm water.

Avoid contact with eyes

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid

Structured Label Content

Use

■ For hand washing to decrease bacteria on the skin

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings (WARNINGS)

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wound

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Directions

Apply a small amount to hands, lather, then rinse with warm water.

Avoid contact with eyes

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients (Inactive ingredients)

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid

Advanced Ingredient Data

[{"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DISODIUM HEDTA", "unii": "KME849MC7A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "■ For hand washing to decrease bacteria on the skin", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition", "Purpose": "Antibacterial", "WARNINGS": "For external use only. Flammable. Keep away from heat or flame Do not use in children less than 2 months of age on open skin wound When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "Directions": "Apply a small amount to hands, lather, then rinse with warm water. Avoid contact with eyes", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Other Information": "Do not store above 105F May discolor some fabrics Harmful to wood finishes and plastics", "Inactive ingredients": "Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:58.643278 · Updated: 2026-03-14T22:58:47.860892