NDC Code(s) : 59316-104-25
Packager : Performance Health, Inc.

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 FLOWER(UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
DIMETHYL SULFONE(UNII: 9H4PO4Z4FT)
ECHINACEA ANGUSTIFOLIA(UNII: VB06AV5US8)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
JUNIPER BERRY(UNII: O84B5194RL)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59316-104-25118 mL in 1 BOTTLE, SPRAY 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 01/15/2013 12/31/2018

PRINCIPAL DISPLAY PANEL

for arthritis, back pain, sore muscles and joints

BIOFREEZE (R)

COLD THERAPY PAIN RELIEF

SOOTHING MENTHOL

VANISHING SCENT

PARABEN-FREE

4 fl oz / 118 mL

Formulated For Authorized Distribution Through Hands-On Health Professionals For The Patients, Clients and Athletes Under Their Care

APPLY FROM ANY ANGLE

EVEN SPRAYS UPSIDE DOWN

NO NSAID's, IBUPROFEN, ASPIRIN OR SALICYLATE

(C) 2012 Performance Health, LLC
1245 Home Avenue
Akron, OH 44310
www.biofreeze.com

panel for biofreeze