NDC Code(s) : 59316-104-10, 59316-104-20, 59316-104-30, 59316-104-25
Packager : RB Health (US) LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BiofreezeMENTHOL SPRAY
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-104
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
(MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) 		MENTHOL, UNSPECIFIED FORM100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARNICA MONTANA WHOLE(UNII: O80TY208ZW)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
CHAMOMILE(UNII: FGL3685T2X)
DIMETHYL SULFOXIDE(UNII: YOW8V9698H)
ECHINACEA, UNSPECIFIED(UNII: 4N9P6CC1DX)
ALCOHOL(UNII: 3K9958V90M)
ILEX PARAGUARIENSIS LEAF(UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
JUNIPERUS COMMUNIS WHOLE(UNII: 464910T5N9)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59316-104-1059 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product25/08/2016
2NDC:59316-104-20118 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product25/08/2016
3NDC:59316-104-30473 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product25/08/2016
4NDC:59316-104-25118 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product29/11/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 11/01/2010

LABELER - RB Health (US) LLC(081049410)

Establishment
Name Address ID/FEI Business Operations
Span Packaging services LLC dba Multi-Pack Solutions 117101131 manufacture(59316-104)

Establishment
Name Address ID/FEI Business Operations
Span Packaging Services LLC dba Multi-Pack Solutions 557434805 manufacture(59316-104)

PRINCIPAL DISPLAY PANEL

PENETRATING, LONG LASTING PAIN RELIEF FROM:
ARTHRITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE ®
PAIN RELIEVING Spray

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ®

16 fl. oz./473mL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label