UNIVERSAL ANTIBACTERIAL WIPES- benzalkonium chloride cloth

UNIVERSAL ANTIBACTERIAL WIPES by

Drug Labeling and Warnings

UNIVERSAL ANTIBACTERIAL WIPES by is a Otc medication manufactured, distributed, or labeled by Monna Kimya Ve Kozmetik Sanayi Ticaret Limited Sirketi. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

INDICATIONS & USAGE

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

WARNINGS

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.

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

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.

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

Packaging

INGREDIENTS AND APPEARANCE

UNIVERSAL ANTIBACTERIAL WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79761-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETEARETH-12 (UNII: 7V4MR24V5P)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79761-101-80	1 in 1 BOX	07/23/2020
1		80 in 1 POUCH
1		3.75 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/23/2020

Labeler - Monna Kimya Ve Kozmetik Sanayi Ticaret Limited Sirketi (355279691)

Establishment
Name	Address	ID/FEI	Business Operations
Monna Kimya Ve Kozmetik Sanayi Ticaret Limited Sirketi		355279691	manufacture(79761-101)