COLEMERG ANTIBACTERIAL HAND SANITIZING WIPES- benzalkonium chloride cloth 
Colemerg Products LLC

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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Colemerg Antibacterial Hand Sanitizing Wipes

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13 % w/v

Purpose

Antibacterial

Uses

WARNINGS

For external use only

Do not use:

Over large areas of the body if you are allegic to any of the ingredients.

When using this product

do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or rash develops and continues for more than 72 hours.

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222)

Directions

Other Information:

Inactive Ingredients:

Aqua/Water, Glycerin, Phenoxyethanol, Parfum/Fragrance, Polysorbate 20, Sodium PCA, Tetrasodium Edta, Ethylhexylglycerin, Citric Acid.

Package Labeling:

label

COLEMERG ANTIBACTERIAL HAND SANITIZING WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80171-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80171-001-00100 in 1 BAG06/26/2020
13.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/26/2020
Labeler - Colemerg Products LLC (117617946)

Revised: 11/2020
Document Id: b3d6e73b-1ffc-4e7f-e053-2a95a90ac1e7
Set id: ad528181-90aa-57cf-e053-2a95a90ad600
Version: 3
Effective Time: 20201111
 
Colemerg Products LLC