GOLDEN MEDICATED- medicated lotion soap solution 
Kutol Products Company

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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Kutol F060

Chloroxylenol 0.3% w/w.......Antibacterial Handwashing

Water, Tall Oil Acid, Potassium Hydroxide, Sodium Lauryl Sulfate, Coconut Acid, Cocamide DIPA, Phenoxyethanol, Tetrasodium EDTA, Sodium Sulfate, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Iodopropynyl Butylcarbamate, Fragrance, Red 33, Yellow 5.

Handwash to help decrease bacteria on the skin.

For external use only.

Do not usein the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor ifirritation or rash appears and lasts.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Handwash to help decrease bacteria on the skin.

Do not use in the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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50865-060-27.jpg  50865-060-27.jpg

GOLDEN MEDICATED 
medicated lotion soap solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
COCONUT ACID (UNII: 40U37V505D)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TALL OIL ACID (UNII: H9HR63474M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50865-060-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2014
2NDC:50865-060-271000 mL in 1 BAG; Type 0: Not a Combination Product03/11/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/11/2014
Labeler - Kutol Products Company (004236139)
Registrant - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(50865-060)

Revised: 8/2023
Document Id: 03fbd386-91bd-0b9a-e063-6394a90ac400
Set id: e6b1f1e4-edf7-4ae9-a16a-5b5a81c94d6d
Version: 3
Effective Time: 20230828
 
Kutol Products Company