Antibacterial Wet Wipes by Positive Promotions Inc. Antibacterial Wet Wipes

Antibacterial Wet Wipes by

Drug Labeling and Warnings

Antibacterial Wet Wipes by is a Otc medication manufactured, distributed, or labeled by Positive Promotions Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth 
Positive Promotions Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antibacterial Wet Wipes

Drug Facts

Active Ingredient

Benzalkonium Chloride (0.13%)

Purpose

Antiseptic

Uses

• For hand-washing to decrease bacteria on skin

WARNING

Flammable. Keep away from heat and flame.

For External use only.

Do not use

in eyes. In case of contact, rinse thoroughly with water.

Stop use & ask doctor

if rash/redness or irritation appears/develops and persist for more than 72 hours.

Keep out of reach of children

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Slowly peel back label and use one wipe. Reseal, keep closed to prevent evaporation. 
• Thoroughly wipe hands, allow to dry out rinsing. 
• Discard after single use 

Other information

• Do not flush down toilet. 
• Keep away from sunlight. Store at room temperature 20°-25°Celsius (68°-77° Fahrenheit)
• May discolor certain fabrics

Inactive Ingredients

Water, Phenoxyethanol, Ethylhexyl Glycerin, Didecyldimonium Chloride, Propylene Glycol, Glycerin, Fragrance.

Package Labeling:

ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79021-006(NDC: 77796-210)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79021-006-15	1 in 1 CARTON	07/01/2021	07/01/2021
1		15 in 1 POUCH
1		3.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/01/2021	07/01/2021

Labeler - Positive Promotions Inc. (002401719)

Revised: 2/2022

Document Id: d79c20a4-688c-0394-e053-2a95a90a760b

34390-5

Set id: c46d9c7f-4452-0aed-e053-2995a90a503e

Version: 2

Effective Time: 20220209