CLARIO ULTRA BLUE ANTIBACTERIAL FOAMING SKIN CLEANSER- benzalkonium chloride soap 
Betco Corporation, Ltd

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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Clario UltraBlue™ Antibacterial Foaming Skin CleanserLuxury Foam Antibacterial Skin Cleanser







Espuma limpiadora antibacteriana de lujo para la piel

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Warnings

  • For external use only. Do not ingest.
  • Avoid contact with eyes.  If contact occurs, rinse thoroughly with water.
  • Stop use and ask a doctor if irritation and redness develop.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • ?Read the entire label before using this product.
  • ?Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
  • Rinse with clean water.

Inactive Ingredients

Water, Phenoxyethanol, Cocamine Oxide, Propylene Glycol, Decyl Glucoside, PEG-4 Rapeseedamide, Cocamidopropyl Hydroxysultaine, Glycerin, Fragrance, Sodium Chloride, Tetrasodium EDTA, Citric Acid, Ethanol, Iodopropynyl Butylcarbamate, Benzyl Acetate, Sodium Glycolate, Sodium Hydroxide, Trisodium Nitrilotriacetate, Diethyl Phthalate, FD&C Blue #1.

Questions? 888-GO BETCO (888-462-3826)

Clario Ultra Blue Antibacterial Foaming Skin Cleanser

Purpose

Antibacterial

Clario Ultra Blue Antibacterial Foaming Skin Cleanser

KEEP OUT OF REACH OF CHILDREN

Clario Ultra Blue Antibacterial Foaming Skin Cleanser

Bag 1000 ml

bag-1000ml

CLARIO ULTRA BLUE ANTIBACTERIAL FOAMING SKIN CLEANSER 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-711
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCAMINE OXIDE (UNII: QWA2IZI6FI)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
PEG-4 RAPESEEDAMIDE (UNII: 89575CN928)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
ALCOHOL (UNII: 3K9958V90M)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
SODIUM GLYCOLATE (UNII: B75E535IMI)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD)  
DIETHYL PHTHALATE (UNII: UF064M00AF)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65601-711-291000 mL in 1 BAG; Type 0: Not a Combination Product11/12/201207/15/2020
2NDC:65601-711-57550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/12/201207/15/2020
3NDC:65601-711-051250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/12/201207/15/2020
4NDC:65601-711-03750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/12/201207/15/2020
5NDC:65601-711-043780 mL in 1 BOTTLE; Type 0: Not a Combination Product11/12/201207/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/12/201207/15/2020
Labeler - Betco Corporation, Ltd (024492831)
Registrant - Betco Corporation, Ltd (024492831)
Establishment
NameAddressID/FEIBusiness Operations
Betco Corporation, Ltd024492831manufacture(65601-711) , label(65601-711)

Revised: 7/2020
Document Id: aa8faff1-82b1-6071-e053-2a95a90adf40
Set id: cd9909da-8c7f-4dcd-8046-b745cc55f2fa
Version: 16
Effective Time: 20200716
 
Betco Corporation, Ltd