MEDROX-RX - methyl salicylate, menthol, capsaicin ointment 
Pharmaceutica North America, Inc.

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.

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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.

box image

                    Rx Only

Medrox-Rx

(medroxcin)     Pain relief ointment

effecive, soothing, long lasting, paraben-free

MEDROX-RX 
methyl salicylate, menthol, capsaicin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:45861-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
methyl salicylate (UNII: LAV5U5022Y) (methyl salicylate - UNII:LAV5U5022Y) methyl salicylate24 g  in 120 g
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol8.4 g  in 120 g
capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM) capsaicin0.6 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45861-005-01120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34810/27/2011
Labeler - Pharmaceutica North America, Inc. (962739699)
Registrant - Pharmaceutica North America, Inc. (962739699)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source969241041manufacture

Revised: 10/2011
Document Id: 0464d781-fa9d-442a-a7a7-94a3c8cf4786
Set id: d9475b6c-edd1-4ea7-a22c-243e63c4d0f7
Version: 8
Effective Time: 20111027
 
Pharmaceutica North America, Inc.