Antibacterial Hand soap

SPL v1

SPL

SPL Set ID ed390aba-247e-486c-9979-a9863a5b4269

Route

TOPICAL

Published

Effective Date 2014-08-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.1 g)

Inactive Ingredients

Water Dmdm Hydantoin Carboxymethylcellulose Sodium Glycerol Formal Lauramidopropyl Betaine Sodium Laureth Sulfate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-08-22

Description

Active Ingredient: Benzalkonium Chloride 0.1%

Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable. Keep away from fire or flame

Do not apply around eyes. Do not use in ears & mouth

When using this product, avoid contatc with eyes. In case of contact, flush eyes with water

Indications and Usage

Uses:

For hand washing to kill bacterial on the skin

Dosage and Administration

Directions:

Wet hands, apply to palms, scrub thoroughly, then rinse.

Description

Active Ingredient: Benzalkonium Chloride 0.1%

Section 50565-1

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9

Stop use and see a doctor if irritation or redness develop and persist for more than 72 hours

Section 51727-6

Inactive Ingredient:

Deionized water, Sodium lauryl polyoxyehthylene ether sulfate, Sodium fatty alcohol ethyl sulfate, Cocoamidoprophyl

betaine, Carboxylmethylcellulose sodium, DMDM Hydantoin, Glycerol, Frangance

Section 51945-4

Section 55105-1

Purpose:

Antiseptic

Section 55106-9

Active Ingredient:

Benzalkonium Chloride 0.1%

Section 60561-8

Other Information:

Store at 20C (68-77F). May discolor fabrics

Structured Label Content

Indications and Usage (34067-9)

Uses:

For hand washing to kill bacterial on the skin

Dosage and Administration (34068-7)

Directions:

Wet hands, apply to palms, scrub thoroughly, then rinse.

Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable. Keep away from fire or flame

Do not apply around eyes. Do not use in ears & mouth

When using this product, avoid contatc with eyes. In case of contact, flush eyes with water

Section 50565-1 (50565-1)

Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use and see a doctor if irritation or redness develop and persist for more than 72 hours

Section 51727-6 (51727-6)

Inactive Ingredient:

Deionized water, Sodium lauryl polyoxyehthylene ether sulfate, Sodium fatty alcohol ethyl sulfate, Cocoamidoprophyl

betaine, Carboxylmethylcellulose sodium, DMDM Hydantoin, Glycerol, Frangance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient:

Benzalkonium Chloride 0.1%

Section 60561-8 (60561-8)

Other Information:

Store at 20C (68-77F). May discolor fabrics

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "72.525", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCEROL FORMAL", "unii": "3L7GR2604E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURAMIDOPROPYL BETAINE", "unii": "23D6XVI233", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURETH SULFATE", "unii": "BPV390UAP0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: For hand washing to kill bacterial on the skin", "34068-7": "Directions: Wet hands, apply to palms, scrub thoroughly, then rinse.", "34071-1": "Warnings For external use only Flammable. Keep away from fire or flame Do not apply around eyes. Do not use in ears & mouth When using this product, avoid contatc with eyes. In case of contact, flush eyes with water", "50565-1": "Keep out of reach of children. Children must be supervised in use of this product.", "50566-9": "Stop use and see a doctor if irritation or redness develop and persist for more than 72 hours", "51727-6": "Inactive Ingredient: Deionized water, Sodium lauryl polyoxyehthylene ether sulfate, Sodium fatty alcohol ethyl sulfate, Cocoamidoprophyl betaine, Carboxylmethylcellulose sodium, DMDM Hydantoin, Glycerol, Frangance", "55105-1": "Purpose: Antiseptic", "55106-9": "Active Ingredient: Benzalkonium Chloride 0.1%", "60561-8": "Other Information: Store at 20C (68-77F). May discolor fabrics"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:49.481823 · Updated: 2026-03-14T22:53:47.887144