NDC Code(s) : 52486-005-01
Packager : MCure Health Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ICE COLD AnalgesicMENTHOL CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52486-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL2 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
CUPRIC SULFATE(UNII: LRX7AJ16DT)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM SULFATE(UNII: DE08037SAB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
THYMOL(UNII: 3J50XA376E)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52486-005-011 in 1 BOX
1227 g in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/05/2015

PRINCIPAL DISPLAY PANEL

Label