MEDROX-RX- methyl salicylate, menthol, capsaicin ointment

Medrox-Rx by

Drug Labeling and Warnings

Medrox-Rx by is a Prescription medication manufactured, distributed, or labeled by Pharmaceutica North America, Inc., Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

methyl salicylate 20.00 % topical analgesic

menthol 7.00 % topical analgesic

capsaicin 0.050 % external analgesic

INACTIVE INGREDIENT

acrylates copolymer, aloe barbadensis leaf (aloe vera gel) juice, aqua (deionized water), cetyl alcohol, ethylhexylglycerin, glycerin, isopropyl myristate, peg-150 disterate, phenoxyethanol, polysorbate-20, sodium lauryl sulfate, triethanolamine

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children. if swallowed, consult physician.

DOSAGE & ADMINISTRATION

apply directly to affected area. do not use more than four times per day.

PURPOSE

for temporary relief of minor aches and pains of the muscles and joints associated with simple arthritis, sprains, bruises and simple backache.

INDICATIONS & USAGE

for temporary relief of minor aches and pains of the muscles and joints associated with simple arthritis, sprains, bruises and simple backache.

WARNINGS

for external use only

avoid contact with eyes

do not bandage or wrap tightly

do not apply to wounds or damages skin

if symptoms persist for more than seven days, discontinue use and consult physician

keep out of reach of children. if swallowed consult physician.

PRINCIPAL DISPLAY PANEL

                    Rx Only

Medrox-Rx

(medroxcin)     Pain relief ointment

effecive, soothing, long lasting, paraben-free

INGREDIENTS AND APPEARANCE

MEDROX-RX 
methyl salicylate, menthol, capsaicin ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 45861-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
methyl salicylate (UNII: LAV5U5022Y) (methyl salicylate - UNII:LAV5U5022Y)	methyl salicylate	24 g  in 120 g
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A)	menthol	8.4 g  in 120 g
capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM)	capsaicin	0.6 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45861-005-01	120 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	10/27/2011

Labeler - Pharmaceutica North America, Inc. (962739699)

Registrant - Pharmaceutica North America, Inc. (962739699)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		969241041	manufacture