UNICOWIPES- benzethonium chloride cloth 
Unicoadds Corp.

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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Active Ingredient                                            Purpose

Benzethonium Chloride 0.2% ....................... Antibacterial

Uses: decreases bacteria on skin

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

Unicowipes

Warnings:

For external use only

Do not use if  you have allergic 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

Directions:

Tear the pack. Pull out the wet wipe. 

Use wet wipe to clean hands, face or legs without soap or water and discard.

Inactive Ingredients

deionized water, cocoamido propyl betain, glycerin pharma, mono propylene glycol, PEG-7 glycery cocoate, polysorbate-20, fragrance, citric acid, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone.

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UNICOWIPES 
benzethonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69651-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.001 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69651-000-001 in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/19/2015
Labeler - Unicoadds Corp. (043612349)
Establishment
NameAddressID/FEIBusiness Operations
Sabah Gida Saglik Temizlik Urunleri Dolum Ve Ambalaj Sana365616970manufacture(69651-000)

Revised: 4/2015
Document Id: a98db59f-0494-4828-bc76-44e3676100eb
Set id: f9cdafba-adf6-425c-88a0-4c1ab3d5420b
Version: 3
Effective Time: 20150423
 
Unicoadds Corp.