NDC Code(s) : 62785-001-01
Packager : GUILIN SANJIN PHARMACEUTICAL CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

WATERMELON FROST SORE THROAT MENTHOL SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62785-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
SCUTELLARIA BAICALENSIS ROOT(UNII: 7J95K7ID2S)
IRIS DOMESTICA WHOLE(UNII: 9IJ63JIC40)
OPHIOPOGON JAPONICUS ROOT(UNII: 90PS6JV9GZ)
SAPOSHNIKOVIA DIVARICATA ROOT(UNII: 8H84LFK2QD)
LONICERA CONFUSA FLOWER(UNII: 3JV904IJ0V)
LICORICE(UNII: 61ZBX54883)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)
SCROPHULARIA NINGPOENSIS ROOT(UNII: HC0FB6P85R)
SODIUM BORATE(UNII: 91MBZ8H3QO)
STEVIOSIDE(UNII: 0YON5MXJ9P)
SOPHORA TONKINENSIS WHOLE(UNII: WL8G39B4EA)
WATERMELON(UNII: 231473QB6R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62785-001-0120 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 03/28/2014

PRINCIPAL DISPLAY PANEL

WATERMELON FROST SORE THROAT SPRAY

NDC-62785-001-01

ORAL PAIN RELIEVER

MENTHOL 2%

20 ML (0.68 FL OZ)IMAGE OF CARTON