NDC Code(s) : 63146-116-03
Packager : Kay Chemical Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mystic Triclosan SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63146-116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN(UNII: 4NM5039Y5X)
(TRICLOSAN - UNII:4NM5039Y5X) 		TRICLOSAN0.3 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POTASSIUM COCOATE(UNII: F8U72V8ZXP)
ALCOHOL(UNII: 3K9958V90M)
SODIUM LAURETH SULFATE(UNII: BPV390UAP0)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
BORIC ACID(UNII: R57ZHV85D4)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE(UNII: H2KVQ74JM4)
EDETATE SODIUM(UNII: MP1J8420LU)
COCAMINE OXIDE(UNII: QWA2IZI6FI)
PEG-75 LANOLIN(UNII: 09179OX7TB)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63146-116-03750 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 11/22/2010

PRINCIPAL DISPLAY PANEL

SSDC

NDC 63146-116-03


MYSTIC

Foaming Anti-Bacterial Hand Soap

Triclosan 0.3%

Net Contents 750 mL/25 US fl oz


Distributed by:

SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100

Grapevine, Texas 76051, USA 800.532.7732


copyright, Kay Chemical Company, All Rights Reserved


 1112019

749431-00 - 749431/7300/0510

 representative label