Your browser does not support JavaScript! GOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]
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GOLDEN MEDICATED (medicated lotion soap) solution
[Kutol Products Company, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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.

  • Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
  • Children under 6 years of age should be supervised when using this product.

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50865-060
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POTASSIUM HYDROXIDE 
COCONUT ACID 
SODIUM LAURYL SULFATE 
PHENOXYETHANOL 
SODIUM LAURETH SULFATE 
IODOPROPYNYL BUTYLCARBAMATE 
SODIUM SULFATE 
D&C RED NO. 33 
FD&C YELLOW NO. 5 
EDETATE SODIUM 
TALL OIL ACID 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
COCO DIISOPROPANOLAMIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50865-060-093785 mL in 1 BOTTLE, PLASTIC
2NDC:50865-060-271000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/11/2014
Labeler - Kutol Products Company, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(50865-060), analysis(50865-060), label(50865-060), pack(50865-060)

Revised: 3/2014
 
Kutol Products Company, Inc.

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