78041-0023 - DailyMed Details

78041-0023

SPL v3

SPL

SPL Set ID a9635bf5-6041-9579-e053-2995a90a38ba

Route

TOPICAL

Published

Effective Date 2020-07-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (1 mg)

Inactive Ingredients

Behentrimonium Chloride Dihydroxyethyl Cocamine Oxide Glycereth-2 Cocoate Water Dihydroxypropyl Peg-5 Linoleammonium Chloride

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-07-01

Description

Benzalkonium Chloride 0.1%

Medication Information

Warnings and Precautions

For external use only - When using this product - do not get into eyes - if contact occurs, rinse eyes thoroughly with water - Stop use and ask a doctor if - irritation and redness ...

Indications and Usage

USE FOR HAND-WASHING TO DECREASE BACTERIA ON THE SKIN

If hands are visibly soiled, use regular soap and water

Recommended for repeated use

Dosage and Administration

Apply to hands and rub lightly until dry without wiping or rinsing

Description

Benzalkonium Chloride 0.1%

Section 50565-1

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

Section 51727-6

Water, Dihydroxy-propyl PEG-5-Linoleammonium Chloride, Glycereth-2 Cocoate, Behentrimonium Chloride, Dihdroxyethyl Cocamine Oxide.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Benzalkonium Chloride 0.1%

Structured Label Content

Indications and Usage (34067-9)

USE FOR HAND-WASHING TO DECREASE BACTERIA ON THE SKIN

If hands are visibly soiled, use regular soap and water

Recommended for repeated use

Dosage and Administration (34068-7)

Apply to hands and rub lightly until dry without wiping or rinsing

Warnings and Precautions (34071-1)

For external use only - When using this product - do not get into eyes - if contact occurs, rinse eyes thoroughly with water - Stop use and ask a doctor if - irritation and redness ...

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 51727-6 (51727-6)

Water, Dihydroxy-propyl PEG-5-Linoleammonium Chloride, Glycereth-2 Cocoate, Behentrimonium Chloride, Dihdroxyethyl Cocamine Oxide.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.1%

Advanced Ingredient Data

[{"name": "BEHENTRIMONIUM CHLORIDE", "unii": "X7GNG3S47T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIHYDROXYETHYL COCAMINE OXIDE", "unii": "8AR51R3BL5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERETH-2 COCOATE", "unii": "JWM00VS7HC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE", "unii": "0Y0NQR2GH1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "USE FOR HAND-WASHING TO DECREASE BACTERIA ON THE SKIN If hands are visibly soiled, use regular soap and water Recommended for repeated use", "34068-7": "Apply to hands and rub lightly until dry without wiping or rinsing", "34071-1": "For external use only - When using this product - do not get into eyes - if contact occurs, rinse eyes thoroughly with water - Stop use and ask a doctor if - irritation and redness ...", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away", "51727-6": "Water, Dihydroxy-propyl PEG-5-Linoleammonium Chloride, Glycereth-2 Cocoate, Behentrimonium Chloride, Dihdroxyethyl Cocamine Oxide.", "55105-1": "Antiseptic", "55106-9": "Benzalkonium Chloride 0.1%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:33.097449 · Updated: 2026-03-14T23:05:22.628914