NDC Code(s) : 0113-0692-21
Packager : L. Perrigo Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

good sense cool heatMenthol, Methyl salicylate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0113-0692
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL10 g in 100 g
METHYL SALICYLATE(UNII: LAV5U5022Y)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		METHYL SALICYLATE30 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CETYL ESTERS WAX(UNII: D072FFP9GU)
OLETH-3 PHOSPHATE(UNII: 8Q0Z18J1VL)
WATER(UNII: 059QF0KO0R)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0113-0692-211 in 1 CARTON
185 g in 1 TUBE 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 04/15/2014

PRINCIPAL DISPLAY PANEL

Extra Strength

Cold & Hot Therapy for Pain

Arthritis – Back Aches – Body Aches – Sore Muscles

Extra Strength

Cool Heat

Pain Relieving Cream

Compare to active ingredient of Icy Hot® Cream

NET WT 3 OZ (85 g)

Good Sense Cool Heat Image 1Good Sense Cool Heat Image 1