NDC Code(s) : 59316-104-50
Packager : Performance Health LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Biofreeze MENTHOL SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59316-104
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARNICA MONTANA(UNII: O80TY208ZW)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
CHAMOMILE(UNII: FGL3685T2X)
DIMETHYL SULFONE(UNII: 9H4PO4Z4FT)
ECHINACEA, UNSPECIFIED(UNII: 4N9P6CC1DX)
ALCOHOL(UNII: 3K9958V90M)
ILEX PARAGUARIENSIS LEAF(UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
JUNIPERUS COMMUNIS WHOLE(UNII: 464910T5N9)
BERRY(UNII: FV3431923Z)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59316-104-5010 in 1 BOX
11 mL in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/19/2011 12/31/2018

PRINCIPAL DISPLAY PANEL

BIOFREEZE PAIN RELIEVING Singles  On-The-Go  HANDS FREE SINGLE USE  10 Single-use applications (1 mL each)  2011 Performance Health, LLC  1245 Home Avenue, Akron, OH 44310

PRINCIPAL DISPLAY PANEL

Biofreeze Singles