DEX ANTIBACTERIAL WIPES- benzalkonium chloride cloth

Dex Antibacterial Wipes by

Drug Labeling and Warnings

Dex Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by Fuson LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride .13% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Antibacterial Wet Hand Wipes

Use

Antibacterial wet wipes helps reduce bacteria (organisms).Effective on bacterias :Staphylococcus aureus ATCC 6538,Pseudomonas aeruginosa ATCC 15442,Enterococcus hirae ATCC 10541,Escherichia coli ATCC 10536. Use only on hands and away from eyes.

Warnings

Keep away from children and direct sunlight. Children should not use this product without an adult supervision. For external use only. In case of poisoning, call the National Toxitation Information Center. Avoid contact with eyes. This product consists of nonwoven fabric (solid) impregnated with a flammable liquid solution that has an estimated flashpoint of approximately 120 degrees fahrenheit; keep away from heat, sparks, open flames, and hot surfaces. Do not smoke near this product or while using. Keep container tightly closed when not in use.

Do Not Use

Do not use if allergic to any of its ingredients. Do not use near eyes. Consult a doctor before use if pregnant, breastfeeding, have sensitive skin, or are under the age of 12. Do not buy opened and/or damaged products.

When Using

In case of inhaling: If you feel uncomfortable get some fresh air. In case of skin Irritation: Occurs stop using the wipes immediately and wash the affected area with water and soap for at least 15 minutes. People with sensitive skin, pregnant women, breastfeeding women and children under the age of 12 should consult a doctor/pharmacist before using the product. Seek for medical advice if necessary. In case of contact with eyes: If you are wearing contact lenses, remove them immediately. Rince your eyes with plenty of clean water. In case of swallowing: Call your local Toxication Center and get medical help.

Stop Using

Stop use if rednedd or irritation occurs and persists for longer than 48 hours and contact a healthcare professional.

KEEP OUT OF REACH OF CHILDREN

Keep away from children. Children should not use this product without adult supervision.

Directions

Provides practical cleaning without need of water and soap. Used for hand cleaning. Open the adhesive label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rinsing required.

Other Information

Do not ingest the product internally. Store in a cool, dry place. Store away from oxidizing agents and food.

Inactive Ingredients

Aqua, Parfum, C12-15 Pareth-12, Glycerin, Polysorbate 20, Propylene Glycol, Tetrasodium EDTA, Piroctone Olamine, Tocopheryl Acetate, Panthenol, Citric Acid

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

DEX ANTIBACTERIAL WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78141-800
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 g

Inactive Ingredients
Ingredient Name	Strength
C12-15 PARETH-12 (UNII: 131316X18L)
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)
EDETATE SODIUM (UNII: MP1J8420LU)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78141-800-02	100 g in 1 POUCH; Type 0: Not a Combination Product	07/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/22/2020

Labeler - Fuson LLC (113376279)