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

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only

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

Purpose

Antibacterial

Directions

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

Inactive Ingredients

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

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

Active Ingredient

Benzalkonium Chloride 0.13%

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

Warnings (WARNINGS)

For external use only

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

Purpose

Antibacterial

Directions

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

Inactive Ingredients (Inactive ingredients)

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

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)

Active Ingredient

Benzalkonium Chloride 0.13%

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