76860-006 - DailyMed Details

76860-006

SPL v1

SPL

SPL Set ID 164209a6-bfde-f1e9-e063-6294a90a2645

Route

TOPICAL

Published

Effective Date 2024-04-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Chlorhexidine Gluconate Polyoxyl 40 Hydrogenated Castor Oil Glycerin Benzethonium Chloride Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-04-17

Description

Purpose

Antibacterial Agent

Medication Information

Purpose

Antibacterial Agent

Description

Use

for hand-washing to decrease bacteria on the skin, only when water is not available

Section 42229-5

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation occurs or rash develops and continues for more than 72 hours.

Section 50567-7

When using the product do not get into eyes. If contact occurs, rinse thoroughly with water.

Section 51945-4

Warnings

For external use only

Directions

adults and children 2 years and over

- apply to hands

- allow skin to dry without wiping

children under 2 years

ask a doctor before use

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Chlorhexidine Digluconate, Benzethonium Chloride, Fragrance (Parfum).

Structured Label Content

Use

for hand-washing to decrease bacteria on the skin, only when water is not available

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation occurs or rash develops and continues for more than 72 hours.

Section 50567-7 (50567-7)

When using the product do not get into eyes. If contact occurs, rinse thoroughly with water.

Section 51945-4 (51945-4)

Purpose

Antibacterial Agent

Warnings

For external use only

Directions

adults and children 2 years and over

- apply to hands

- allow skin to dry without wiping

children under 2 years

ask a doctor before use

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Chlorhexidine Digluconate, Benzethonium Chloride, Fragrance (Parfum).

Advanced Ingredient Data

[{"name": "CHLORHEXIDINE GLUCONATE", "unii": "MOR84MUD8E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZETHONIUM CHLORIDE", "unii": "PH41D05744", "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, only when water is not available", "42229-5": "NA", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation occurs or rash develops and continues for more than 72 hours.", "50567-7": "When using the product do not get into eyes. If contact occurs, rinse thoroughly with water.", "Purpose": "Antibacterial Agent", "Warnings": "For external use only", "Directions": "adults and children 2 years and over - apply to hands - allow skin to dry without wiping children under 2 years ask a doctor before use", "Active Ingredient(s)": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Chlorhexidine Digluconate, Benzethonium Chloride, Fragrance (Parfum)."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:59.886769 · Updated: 2026-03-14T23:02:50.389879