GOLDEN MEDICATED- medicated lotion soap solution

Golden Medicated by

Drug Labeling and Warnings

Golden Medicated by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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.

PURPOSE

Handwash to help decrease bacteria on the skin.

WARNINGS

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.

DOSAGE & ADMINISTRATION

• 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.

INDICATIONS & USAGE

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

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

PRINCIPAL DISPLAY PANEL

50865-060-09.jpg

PRINCIPAL DISPLAY PANEL

  50865-060-27.jpg

INGREDIENTS AND APPEARANCE

GOLDEN MEDICATED 
medicated lotion soap solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-060
Route of Administration	TOPICAL

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; Type 0: Not a Combination Product	03/11/2014
2	NDC: 50865-060-27	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/11/2014

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)