Medrox-Rx Ointment

Generic Name: methyl salicylate, menthol, capsaicin

Dosage Form: ointment
Medrox-Rx

methyl salicylate 20.00 % topical analgesic

menthol 7.00 % topical analgesic

capsaicin 0.050 % external analgesic

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. if swallowed, consult physician.

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

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

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

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.

                    Rx Only

Medrox-Rx

(medroxcin)     Pain relief ointment

effecive, soothing, long lasting, paraben-free

MEDROX-RX  methyl salicylate, menthol, capsaicin  ointment

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength methyl salicylate (methyl salicylate) methyl salicylate 24 g  in 120 g menthol (menthol) menthol 8.4 g  in 120 g capsaicin (capsaicin) capsaicin 0.6 g  in 120 g

Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A   ALOE VERA LEAF   WATER   CETYL ALCOHOL   ETHYLHEXYLGLYCERIN   GLYCERIN   ISOPROPYL MYRISTATE   PEG-150 DISTEARATE   PHENOXYETHANOL   POLYSORBATE 20   SODIUM LAURYL SULFATE   TROLAMINE   FD&C BLUE NO. 1   FD&C YELLOW NO. 5

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45861-005-01 120 g In 1 TUBE None

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	Operations
Pure Source		969241041	manufacture

Revised: 10/2011Pharmaceutica North America, Inc.