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SPL v3

SPL

SPL Set ID 0f224014-3b77-7188-e063-6394a90a4c2d

Route

TOPICAL

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.01 mg)

Inactive Ingredients

Cocamidopropyl Pg-dimonium Chloride Phosphate Alcohol 1-ethoxyundecane Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-17

Description

Benzalkonium Chloride 0.1%.........-: oa Antimicrobial

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.1%.........-: oa Antimicrobial

Use

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use

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 or redness develops, —

or if the condition persists for more than 72 hours.

Section 50567-7

Do not use in or near the eyes. In case of contact with eyes flush thoroughly with water.

Warnings

Warnings For external use only

When using this, avoid contact with the eyes. In case of eye contact, flush eyes with water.

Directions

Apply to hands, Allow skin to dry without wiping

Active Ingredient(s)

Benzalkonium Chloride 0.1%.........-: oa Antimicrobial

Inactive Ingredients

Water, Ethyl Alcohol, Coamidoporpyl PGDimonium, Chloride Phosphate, Linear Alcohol Ethoxylate, Fragrance

Package Label Principal Display Panel

NDC: 80436-005-01

Structured Label Content

Use

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use

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 or redness develops, —

or if the condition persists for more than 72 hours.

Section 50567-7 (50567-7)

Do not use in or near the eyes. In case of contact with eyes flush thoroughly with water.

Purpose

Antimicrobial

Warnings

Warnings For external use only

When using this, avoid contact with the eyes. In case of eye contact, flush eyes with water.

Directions

Apply to hands, Allow skin to dry without wiping

Active Ingredient(s)

Benzalkonium Chloride 0.1%.........-: oa Antimicrobial

Inactive Ingredients (Inactive ingredients)

Water, Ethyl Alcohol, Coamidoporpyl PGDimonium, Chloride Phosphate, Linear Alcohol Ethoxylate, Fragrance

Package Label Principal Display Panel (Package Label - Principal Display Panel)

NDC: 80436-005-01

Advanced Ingredient Data

[{"name": "COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE", "unii": "H2KVQ74JM4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.01", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "1-ETHOXYUNDECANE", "unii": "R428J6A8Q2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use", "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 or redness develops, — or if the condition persists for more than 72 hours.", "50567-7": "Do not use in or near the eyes. In case of contact with eyes flush thoroughly with water.", "Purpose": "Antimicrobial", "Warnings": "Warnings For external use only When using this, avoid contact with the eyes. In case of eye contact, flush eyes with water.", "Directions": "Apply to hands, Allow skin to dry without wiping", "Active Ingredient(s)": "Benzalkonium Chloride 0.1%.........-: oa Antimicrobial", "Inactive ingredients": "Water, Ethyl Alcohol, Coamidoporpyl PGDimonium, Chloride Phosphate, Linear Alcohol Ethoxylate, Fragrance", "Package Label - Principal Display Panel": "NDC: 80436-005-01"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:50.701541 · Updated: 2026-03-14T23:11:44.718615