Medrox-Rx Ointment

Generic Name: methyl salicylate, menthol, capsaicin
Dosage Form: ointment

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
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 Operations
Pure Source 969241041 manufacture
Revised: 10/2011
 
Pharmaceutica North America, Inc.



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