50563-264/jas21f04

SPL v1

SPL

SPL Set ID 353bbfeb-37be-462f-a378-62e14f039e0a

Route

TOPICAL

Published

Effective Date 2020-09-23

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 .alpha.-tocopherol Acetate Water Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-09-23

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 50566-9

Stop use and ask a doctor if skin irritation develops.

Section 51945-4

Warnings

For external use only

When suing this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Directions

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

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Tocopheryl Acetate, Blue 1, Yellow 5

Keep Out of Reach of Children

Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.

Structured Label Content

Use

■ For hand washing to decrease bacteria on the skin

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation develops.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings (WARNINGS)

For external use only

When suing this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Directions

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

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Tocopheryl Acetate, Blue 1, Yellow 5

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

Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.

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": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "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", "50566-9": "Stop use and ask a doctor if skin irritation develops.", "Purpose": "Antibacterial", "WARNINGS": "For external use only When suing this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.", "Directions": "Apply a small amount to hands, lather for seconds, then rinse with warm water.", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Tocopheryl Acetate, Blue 1, Yellow 5", "keep out of reach of children": "Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:46.744220 · Updated: 2026-03-14T22:58:31.850591