PEARLIZED ANTIBACTERIAL SKIN CLEANSER- chloroxylenol liquid

Pearlized Antibacterial Skin Cleanser by

Drug Labeling and Warnings

Pearlized Antibacterial Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Fastenal, Betco corporation, Ltd., Betco Corporation, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Chloroxylenol 0.40%

Uses

• ​​Antibacterial hand cleaner.
• Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

Warnings

• For external use only.
• Avoid contact with eyes.
• Children under the age of 6 should be supervised by an adult when using this product.
• Discontinue use is irritation or redness develops.
• 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, Sodium Laureth lSulfate, Cocamidopropyl betadine, Phenoxyethanol, Coco MIPA, Glycol Stearate, DMDM Hydantoin, Propylene Glycol, Sodium Chloride, Fragrance, Glycerin, Ethanol,  D&C Green #5, FD&C Yellow #5.

Purpose

Antibacterial

KEEP OUT OF REACH OF CHILDREN

Winning Hands Antibacterial

KEEP OUT OF REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

©2017 Betco Corporation
400 Van Camp Road Bowling Green, Ohio 43402
Made In U.S.A. All Rights Reserved.

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEARLIZED ANTIBACTERIAL SKIN CLEANSER 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72024-841
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
4-ACETOXY-3-PENTYLTETRAHYDROPYRAN (UNII: 30E3255185)
SODIUM BENZOATE (UNII: OJ245FE5EU)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)
HEXYL SALICYLATE (UNII: 8F78EY72YL)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)
SODIUM CARBONATE (UNII: 45P3261C7T)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CALCIUM SILICATE (UNII: S4255P4G5M)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
BENZYL ACETATE (UNII: 0ECG3V79ZJ)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y)
DIHYDROMYRCENOL (UNII: 46L1B02ND9)
HEXAHYDRO-4,7-METHANOINDEN-6-YL PROPIONATE (UNII: S3ASM14UAS)
VERDYL ACETATE (UNII: 5232EN3X2F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72024-841-04	3780 mL in 1 JUG; 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 Drug	505G(a)(3)	11/12/2012

Labeler - Fastenal (042653634)

Registrant - Betco corporation, Ltd. (005050158)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corporation, Ltd.		005050158	label(72024-841) , manufacture(72024-841)