NDC Code(s) : 71123-001-10
Packager : Gelnova Laboratories (India) Private Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PhytoRelief CC Menthol LOZENGE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71123-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL7 mg
Inactive Ingredients
Ingredient Name Strength
POMEGRANATE(UNII: 56687D1Z4D)
GELATIN(UNII: 2G86QN327L)
GINGER(UNII: C5529G5JPQ)
EUCALYPTUS OIL(UNII: 2R04ONI662)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
GLYCERIN(UNII: PDC6A3C0OX)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)
SPEARMINT(UNII: J7I2T6IV1N)
TURMERIC(UNII: 856YO1Z64F)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SUCRALOSE(UNII: 96K6UQ3ZD4)
Product Characteristics
Color brown (DARK BROWN) Score no score
Shape RECTANGLE (Lozenge) Size 14 mm
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71123-001-1010 in 1 BOX Type 0: Not a Combination Product01/04/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/04/2017

PRINCIPAL DISPLAY PANEL

Package Label