ANTIBACTERIAL LOTIONS SKIN CLEANSER- chloroxylenol soap

Antibacterial Lotions Skin Cleanser by

Drug Labeling and Warnings

Antibacterial Lotions Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by 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 Chloride, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Ethylene Glycol Phenyl Ether, Glycerin, Fragrance, Propylene Glycol, Sodium Hydroxide, Cocamidopropylamine Oxide, Sodium Benzoate, Glycol Distearate, Lauramide MIPA, Disodium Cocamido MIPA Sulfosuccinate, D&C Green 5, FD&C Yellow 5.

Purpose

Antibacterial

KEEP OUT OF REACH OF CHILDREN

Antibacterial Lotion Skin Cleanser

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.

888-GO BETCO (888-462-3826) | Betco.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL LOTIONS SKIN CLEANSER 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65601-841
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
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
VERDYL ACETATE (UNII: 5232EN3X2F)
1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
4-ACETOXY-3-PENTYLTETRAHYDROPYRAN (UNII: 30E3255185)
DIHYDROMYRCENOL (UNII: 46L1B02ND9)
LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)
SODIUM CARBONATE (UNII: 45P3261C7T)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
BENZYL ACETATE (UNII: 0ECG3V79ZJ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HEXYL SALICYLATE (UNII: 8F78EY72YL)
HEXAHYDRO-4,7-METHANOINDEN-6-YL PROPIONATE (UNII: S3ASM14UAS)
CALCIUM SILICATE (UNII: S4255P4G5M)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
ETHYLENE OXIDE (UNII: JJH7GNN18P)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65601-841-04	3780 mL in 1 JUG; Type 0: Not a Combination Product	02/01/2016
2	NDC: 65601-841-19	900 mL in 1 BAG; Type 0: Not a Combination Product	02/01/2016
3	NDC: 65601-841-55	207900 mL in 1 DRUM; Type 0: Not a Combination Product	02/01/2016
4	NDC: 65601-841-10	1100 mL in 1 BAG; Type 0: Not a Combination Product	02/01/2016
5	NDC: 65601-841-29	1000 mL in 1 BAG; Type 0: Not a Combination Product	11/12/2012
6	NDC: 65601-841-88	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/11/2020

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 - Betco Corporation, Ltd. (005050158)

Registrant - Betco corporation, Ltd. (005050158)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corporation, Ltd.		005050158	label(65601-841) , manufacture(65601-841)