CLEA FANTASY ALCOHOL WIPES- alcohol wipes swab 
COTTON CLUB TR HIJYENIK VE KIMYEVI ÜRÜNLER SAN.VE DIŞ TIC.AŞ.

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.

----------

Active Ingredient Section

OTC Principle Display PanelOTC Active

Dosage & Administration Section

Warning Section

Inactive Ingredients Section

Indications & usage section

OTC-keep out of reach of children section

OTC-Purpose section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLEA FANTASY ALCOHOL WIPES 
alcohol wipes swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79585-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL45 mL  in 75 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL30 mL  in 75 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79585-050-5050 mL in 1 POUCH; Type 0: Not a Combination Product08/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/11/2020
Labeler - COTTON CLUB TR HIJYENIK VE KIMYEVI ÜRÜNLER SAN.VE DIŞ TIC.AŞ. (355616318)
Establishment
NameAddressID/FEIBusiness Operations
COTTON CLUB TR HIJYENIK VE KIMYEVI ÜRÜNLER SAN.VE DIŞ TIC.AŞ.355616318manufacture(79585-050)

Revised: 7/2020
Document Id: a98fa752-457b-54c5-e053-2995a90aea9f
Set id: a98fa752-457a-54c5-e053-2995a90aea9f
Version: 1
Effective Time: 20200703
 
COTTON CLUB TR HIJYENIK VE KIMYEVI ÜRÜNLER SAN.VE DIŞ TIC.AŞ.