SPL v1
SPL
SPL Set ID 1de720e7-a113-8f79-e063-6294a90a2f96
Route
TOPICAL
Published
Effective Date 2023-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Cocamidopropyl Betaine Sodium Cocoamphoacetate Iodopropynyl Butylcarbamate Citric Acid Monohydrate Methylisothiazolinone D&c Red No. 33 Fd&c Blue No. 1 Peg-150 Distearate Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Benzalkonium Chloride 0.13 percent

Purpose

Antibacterial


Medication Information

Indications and Usage

kill germs and odors

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13 percent

Section 51945-4

Warning:

Aoid contact with eyes. In case of contact, flush with water.

Keep out of direct sunlight.

Do not drink, not edible.

External use only.

Directions:

Pump a small amount of soap into wet hands, rub hands together to create rich lather, then rinse.

Active Ingredient

Benzalkonium Chloride 0.13 percent

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Sodium Cocoamphoacetate, PEG-150 Distearate, Fragrance, PEG-40 Hydrogenated Castor Oil, Citric Acid, Methylisothiazolinone, Iodopropynyl Butylcarbamate, D&C Red No. 33, FD&C Blue No.1


Structured Label Content

Indications and Usage (34067-9)

kill germs and odors

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warning:

Aoid contact with eyes. In case of contact, flush with water.

Keep out of direct sunlight.

Do not drink, not edible.

External use only.

Directions:

Pump a small amount of soap into wet hands, rub hands together to create rich lather, then rinse.

Active Ingredient

Benzalkonium Chloride 0.13 percent

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Sodium Cocoamphoacetate, PEG-150 Distearate, Fragrance, PEG-40 Hydrogenated Castor Oil, Citric Acid, Methylisothiazolinone, Iodopropynyl Butylcarbamate, D&C Red No. 33, FD&C Blue No.1


Advanced Ingredient Data


Raw Label Data

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