Active Ingredient

Chloroxylenol 0.375%

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

Winning Hands Antibacterial

KEEP OUT OF REACH OF CHILDREN

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

ANTIBACTERIAL SKIN CLEANSER
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65601-708
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3.75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALCOHOL (UNII: 3K9958V90M)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
DIMETHYL BENZYL CARBINYL BUTYRATE (UNII: 3Q0C60547R)
ETHYL BUTYRATE (UNII: UFD2LZ005D)
SODIUM FERROCYANIDE (UNII: 5HT6X21AID)
ETHYL ACETOACETATE (UNII: IZP61H3TB1)
LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)
SODIUM CARBONATE (UNII: 45P3261C7T)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)
CHLOROACETIC ACID (UNII: 5GD84Y125G)
IONONE (UNII: QP734LIN1K)
BENZYL BENZOATE (UNII: N863NB338G)
MYRCENE (UNII: 3M39CZS25B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYL ANTHRANILATE (UNII: 981I0C1E5W)
DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H)
CALCIUM SILICATE (UNII: S4255P4G5M)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYL ALCOHOL (UNII: Y4S76JWI15)
ETHYLENE OXIDE (UNII: JJH7GNN18P)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DIOXANE (UNII: J8A3S10O7S)
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)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65601-708-04	3780 mL in 1 JUG; Type 0: Not a Combination Product	02/01/2016
2	NDC:65601-708-19	900 mL in 1 BAG; Type 0: Not a Combination Product	02/01/2016
3	NDC:65601-708-41	2000 mL in 1 BAG; Type 0: Not a Combination Product	02/01/2016	07/15/2020
4	NDC:65601-708-55	207900 mL in 1 DRUM; Type 0: Not a Combination Product	02/01/2016
5	NDC:65601-708-10	1100 mL in 1 BAG; Type 0: Not a Combination Product	02/01/2016
6	NDC:65601-708-29	1000 mL in 1 BAG; Type 0: Not a Combination Product	11/12/2012
7	NDC:65601-708-88	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/12/2012

Labeler - Betco Corporation, Ltd. (024492831)

Registrant - Betco corporation, Ltd. (024492831)