U

U
SPL v1
SPL
SPL Set ID 7e429ccb-5dda-4db1-8efa-0f8fb944a6f3
Route
TOPICAL
Published
Effective Date 2020-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Phenoxyethanol Benzoic Acid Dehydroacetic Acid Cetearyl Isononanoate Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glyceryl Monostearate Ceteareth-12 Cetyl Palmitate Cocamidopropyl Betaine Glycerin Edetate Sodium Allantoin Panthenol Disodium Laureth Sulfosuccinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-23

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Warnings and Precautions

Warnings: For external use only.

Do not use: ▪ In the eyes.

▪ If you are allergic to any of the ingredients.

When using this product: if eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor: if irritation and redness develops and persists for more than 72 hours.

Indications and Usage

Uses: For Hand cleaning to decrease bacteria on the skin.

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Section 42229-5

NEW

ANTIBACTERIAL WIPES

Kill 99.9% OF VIRUS & BACTERIA

+ 99.9% germ protection

+ fast acting formula

+ safe on skin & hands

Anti-Bacterial Wipes are superb for quick, easy and intelligent clean-up of your skin and hands. • wipes are specifically formulated wipes that cleans virus and bacteria efficaciously and cautiously. Universal Anti-Bacterial Wipes can be easily used on skin, hands and other body parts.

Distributed By:

Univeral Distribution Center L.L.C.,

Edison, NJ 08817

www.universaldc.com

www.universalbrandsusa.com

Made in Turkey

Section 50565-1

Keep out of reach of children except with adult supervision: If swallowed get medical help or contact a Poison Control Center immediately.

Section 51727-6

Inactive ingredients   water, Phenoxyethanol, benzoic acid, dehydroacetic acid, cetearyl isononanoate, ceteareth-20, cetearyl alcohol, glyceryl stearate, ceteareth-12, cetyl palmitate, cocamidopropyl betaine, fragrance, glycerin, tetrasodium EDTA, allantoin, panthenol, disodium laureth sulfosuccinate

Packaging

Directions

To Dispense: Pull-up the lid placed on top of the pouch. Tear straight across to open. Pull first wipe from center of the pouch opening. 

For use: Gently pull wipe from the center of the pouch. Wipe your hands and skin thoroughly with wipe and let dry. Discard wipe in trash.

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

Uses: For Hand cleaning to decrease bacteria on the skin.

Warnings and Precautions (34071-1)

Warnings: For external use only.

Do not use: ▪ In the eyes.

▪ If you are allergic to any of the ingredients.

When using this product: if eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor: if irritation and redness develops and persists for more than 72 hours.

Section 42229-5 (42229-5)

NEW

ANTIBACTERIAL WIPES

Kill 99.9% OF VIRUS & BACTERIA

+ 99.9% germ protection

+ fast acting formula

+ safe on skin & hands

Anti-Bacterial Wipes are superb for quick, easy and intelligent clean-up of your skin and hands. • wipes are specifically formulated wipes that cleans virus and bacteria efficaciously and cautiously. Universal Anti-Bacterial Wipes can be easily used on skin, hands and other body parts.

Distributed By:

Univeral Distribution Center L.L.C.,

Edison, NJ 08817

www.universaldc.com

www.universalbrandsusa.com

Made in Turkey

Section 50565-1 (50565-1)

Keep out of reach of children except with adult supervision: If swallowed get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive ingredients   water, Phenoxyethanol, benzoic acid, dehydroacetic acid, cetearyl isononanoate, ceteareth-20, cetearyl alcohol, glyceryl stearate, ceteareth-12, cetyl palmitate, cocamidopropyl betaine, fragrance, glycerin, tetrasodium EDTA, allantoin, panthenol, disodium laureth sulfosuccinate

Purpose

Antibacterial

Packaging

Directions

To Dispense: Pull-up the lid placed on top of the pouch. Tear straight across to open. Pull first wipe from center of the pouch opening. 

For use: Gently pull wipe from the center of the pouch. Wipe your hands and skin thoroughly with wipe and let dry. Discard wipe in trash.

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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