g0abhw04 - DailyMed Details

g0abhw04

SPL v1

SPL

SPL Set ID 61d79140-0074-4ffe-b3d5-69f3f2f212e3

Route

topical

Published

Effective Date 2020-06-30

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 fd&c yellow no. 5 fd&c red no. 4

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-06-30

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only

Purpose

Antibacterial

Directions

Pump soap into dry hands. Lather for at least 20 seconds and rinse thoroughly

Inactive Ingredients

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Yellow 5, Red 4

Description

Benzalkonium Chloride 0.13%

Use

■ To decrease bacteria on hands

Section 50566-9

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

Section 51945-4

Active Ingredient

Benzalkonium Chloride 0.13%

Keep Out of Reach of Children

Keep out of reach of children

Structured Label Content

Warnings (WARNINGS)

For external use only

Purpose

Antibacterial

Directions

Pump soap into dry hands. Lather for at least 20 seconds and rinse thoroughly

Inactive Ingredients (Inactive ingredients)

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Yellow 5, Red 4

Use

■ To decrease bacteria on hands

Section 50566-9 (50566-9)

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

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

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": "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": "■ To decrease bacteria on hands", "50566-9": "Do not use if you are allergic to any ingredients listed Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours Do not get into eyes. Rinse thoroughly with water if contact occurs", "Purpose": "Antibacterial", "WARNINGS": "For external use only", "Directions": "Pump soap into dry hands. Lather for at least 20 seconds and rinse thoroughly", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Yellow 5, Red 4", "keep out of reach of children": "Keep out of reach of children"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:04.526229 · Updated: 2026-03-14T22:57:27.471846