ULTRA BLUE ANTIBACTERIAL FOAMING SKIN CLEANSER- benzalkonium chloride soap

Ultra Blue Antibacterial Foaming Skin Cleanser by

Drug Labeling and Warnings

Ultra Blue Antibacterial Foaming Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Betco Corporation, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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-1000ml

INGREDIENTS AND APPEARANCE

ULTRA BLUE ANTIBACTERIAL FOAMING SKIN CLEANSER 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65601-759
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMINE OXIDE (UNII: QWA2IZI6FI)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-4 RAPESEEDAMIDE (UNII: 89575CN928)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE SODIUM (UNII: MP1J8420LU)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ACETATE (UNII: 0ECG3V79ZJ)
SODIUM GLYCOLATE (UNII: B75E535IMI)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE (UNII: 452GFV2AFS)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
GERANIOL (UNII: L837108USY)
LIME OIL (UNII: UZH29XGA8G)
2-METHYLUNDECANAL (UNII: S94QNS2VY5)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
ALLYL CYCLOHEXANEPROPIONATE (UNII: H4W9H3L241)
GERANYL ACETATE (UNII: 3W81YG7P9R)
CITRONELLYL ACETATE (UNII: IZ420RT3OY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRAL (UNII: T7EU0O9VPP)
FORMALDEHYDE (UNII: 1HG84L3525)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65601-759-29	1000 mL in 1 BAG; Type 0: Not a Combination Product	11/12/2012
2	NDC: 65601-759-57	550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/12/2012
3	NDC: 65601-759-03	750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/12/2012
4	NDC: 65601-759-04	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2012
5	NDC: 65601-759-88	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/12/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/12/2012

Labeler - Betco Corporation, Ltd (024492831)

Registrant - Betco Corporation, Ltd (024492831)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corporation, Ltd		024492831	manufacture(65601-759) , label(65601-759)