50563-421/jas21fcf

SPL v1

SPL

SPL Set ID 3beec357-2277-4d5d-b5c6-51a3e300ce01

Route

TOPICAL

Published

Effective Date 2021-03-26

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 Yellow No. 5 Fd&c Red No. 4

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-03-26

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

Section 50566-9

Stop use and ask a doctor if skin irritation develops.

Section 51945-4

Warnings

For external use only

When using 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 20 seconds, then rinse with warm water.

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, Tocopheryl Acetate, Red 4, Yellow 5

Structured Label Content

Use

■ For hand washing to decrease bacteria on the skin

Section 50565-1 (50565-1)

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

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 using 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 20 seconds, then rinse with warm water.

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, Tocopheryl Acetate, Red 4, Yellow 5

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 YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 4", "unii": "X3W0AM1JLX", "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. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.", "50566-9": "Stop use and ask a doctor if skin irritation develops.", "Purpose": "Antibacterial", "WARNINGS": "For external use only When using 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 20 seconds, then rinse with warm water.", "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, Tocopheryl Acetate, Red 4, Yellow 5"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:28.210277 · Updated: 2026-03-14T22:59:28.137987