GERMS BE GONE ANTISEPTIC WIPES SCENTED- benzalkonium chloride cloth 
Brands International corporation

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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Germs Be Gone Antiseptic wipes. Scented

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Kills (harmful) bacteria/germs to provide antiseptic cleansing

Use

Kills (harmful) bacteria/germs.

Warnings

For extenal use only.

Avoid contact with eyes. if contact occurs, rinse thoroughly with water.

 If irritation develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Water, Glycerin, Parfume, Dicaprylyl Carbonate, Glyceryl Oleate, Lauryl glucoside, Olus oil, Polyglyceryl-2Dipolyhydroxystearate

Phenoxyethanol, Polysorbate 20, Benzoic acid, Tetrasodium EDTA, Dehydroacetic acid, Propylene glycol

Package Label - Principal Display Panel

12

GERMS BE GONE ANTISEPTIC WIPES  SCENTED
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-522
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13   in 100 
Inactive Ingredients
Ingredient NameStrength
EDETATE SODIUM (UNII: MP1J8420LU)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50157-522-1515 in 1 PACKAGE; Type 0: Not a Combination Product08/12/2021
2NDC:50157-522-8080 in 1 PACKAGE; Type 0: Not a Combination Product08/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/11/2021
Labeler - Brands International corporation (243748238)
Registrant - Brands International corporation (243748238)
Establishment
NameAddressID/FEIBusiness Operations
Brands International corporation243748238manufacture(50157-522)

Revised: 8/2021
Document Id: c98944f8-94b8-d260-e053-2995a90a5ed7
Set id: c98944ea-6e7f-118a-e053-2a95a90aa1e2
Version: 1
Effective Time: 20210814
 
Brands International corporation