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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

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%


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

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.

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

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%


Structured Label Content

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.

Indications and Usage (34067-9)

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

Purpose

Antibacterial

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.

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

Packaging

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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