GOLDEN MEDICATED- chloroxylenol solution 
Kutol Products Company, Inc.

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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Golden Medicated

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 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.

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.

50865-060-09.jpg  50865-060-09.jpg

50865-060-27.jpg  50865-060-27.jpg

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

GOLDEN MEDICATED 
medicated lotion soap solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50865-060
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.3 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:50865-060-09 3785 mL in 1 BOTTLE, PLASTIC
2 NDC:50865-060-27 1000 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/11/2014
Labeler - Kutol Products Company, Inc. (004236139)
Establishment
Name Address ID/FEI Business Operations
Kutol Products Company, Inc. 004236139 manufacture(50865-060) , analysis(50865-060) , label(50865-060) , pack(50865-060)

Revised: 3/2014
Document Id: dac6322d-29a0-4794-ae58-f715a99c8beb
Set id: e6b1f1e4-edf7-4ae9-a16a-5b5a81c94d6d
Version: 1
Effective Time: 20140328
 
Kutol Products Company, Inc.