Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID c453c64a-c1b6-4ac5-8870-72ff2e720db5
Route
TOPICAL
Published
Effective Date 2021-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Pentylene Glycol Glyceryl Caprylate/caprate Peg/ppg-18/18 Dimethicone Sodium Cocoamphoacetate Cocamidopropyl Betaine Water Hydrogenated Castor Oil Citric Acid Monohydrate Edetate Disodium Aloe Vera Leaf Glycerin Disodium Cocoamphodiacetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-24

Description

Benzalkonium Chloride 0.13%


Medication Information

Description

Benzalkonium Chloride 0.13%

Ingredients:

Aqua, Pentylene Glycol and Glyceryl Caprylate / Caprate, Dimethicone copolyol, PEG 40 Hydrogenated Castor Oil, Tocopheryl Acetate (Vitamin E), Glycerine, Sodium cocoamphodiacetate, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, Aloe Barbadensis Leaf Juice.

Precautions:

Do not apply to irritated or damaged skin. In case of gluteal erythema (redness of skin), contact your doctor or pharmacist. Keep in a cool place away from direct sunlight. Prevent contact with eyes. In case of irritation wash away with water immediately.

Product Label

Active Ingredient

Benzalkonium Chloride 0.13%

Direction of Use:

Open the flip top / peel back the front label slowly. Pull wipes as needed. Reseal pouch by firmly running thumb over label / close the flip top to prevent moisture loss.


Structured Label Content

Ingredients:

Aqua, Pentylene Glycol and Glyceryl Caprylate / Caprate, Dimethicone copolyol, PEG 40 Hydrogenated Castor Oil, Tocopheryl Acetate (Vitamin E), Glycerine, Sodium cocoamphodiacetate, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, Aloe Barbadensis Leaf Juice.

Precautions:

Do not apply to irritated or damaged skin. In case of gluteal erythema (redness of skin), contact your doctor or pharmacist. Keep in a cool place away from direct sunlight. Prevent contact with eyes. In case of irritation wash away with water immediately.

Product Label (Product label)

Active Ingredient

Benzalkonium Chloride 0.13%

Direction of Use: (Direction of use:)

Open the flip top / peel back the front label slowly. Pull wipes as needed. Reseal pouch by firmly running thumb over label / close the flip top to prevent moisture loss.


Advanced Ingredient Data


Raw Label Data

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