SKIN CLEANSER- chloroxylenol 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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Medicated Lotion Skin Cleanser

Medicated Lotion Skin Cleanser

​Active Ingredient

​Chloroxylenol 0.5%

Knuckle Under Medicated

Uses

Knuckle Under Medicated

Warnings

Knuckle Under Medicated

Directions

Knuckle Under Medicated

Inactive Ingredients

​Water, sodium tallate, Sodium Laureth Sulfate, Triisopropanolamine, Alcohol, Tetrasodium EDTA, Sodium Chloride, Coco MIPA, Fragrance,  Cocamidopropropyl Betaine, Glycerin, Methyl Chlorosiothiazolinone, D&C Green #5, FD&C Yellow #5.

Knuckle Under Medicated

Purpose

Antibacterial

Knuckle Under Medicated

KEEP OUT OF REACH OF CHILDREN

Medicated Lotion Skin Cleanser

label-1

label-2

label-3

SKIN CLEANSER 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-865
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD)  
METHYL ALCOHOL (UNII: Y4S76JWI15)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TALL OIL ACID (UNII: H9HR63474M)  
ALCOHOL (UNII: 3K9958V90M)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
FORMALDEHYDE (UNII: 1HG84L3525)  
DIOXANE (UNII: J8A3S10O7S)  
SODIUM FERROCYANIDE (UNII: 5HT6X21AID)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SODIUM GLYCOLATE (UNII: B75E535IMI)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65601-865-043780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2016
2NDC:65601-865-063780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/12/2012
3NDC:65601-865-55208000 mL in 1 DRUM; Type 0: Not a Combination Product11/12/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/12/2012
Labeler - Betco Corporation, Ltd. (024492831)
Registrant - Betco corporation, Ltd. (024492831)
Establishment
NameAddressID/FEIBusiness Operations
Betco Corporation, Ltd.024492831manufacture(65601-865) , label(65601-865) , pack(65601-865)

Revised: 7/2020
Document Id: aa91475b-ea85-afe9-e053-2a95a90ad0aa
Set id: aa913134-c6a0-2920-e053-2a95a90a3be2
Version: 1
Effective Time: 20200716
 
Betco Corporation, Ltd.