MEDROX  - methyl salicylate, menthol, capsaicin  ointment 
H.J. Harkins Company, 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 (Medroxin)

DRUG FACTS:

ACTIVE INGREDIENTS

Methyl Salicylate      20.00%

Menthol                     5.00%

Capsaicin                  0.0375%

PURPOSE

Analgesic/Counterirritant

Analgesic/Counterirritant

External Analgesic

USES

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

WARNINGS


KEEP OUT OF REACH OF CHILDREN

Consult physician for children under 12.


DIRECTIONS


Apply product directly to affected area. Product may be used as necessary, but should not be used more than four times per day.


OTHER INGREDIENTS


Deionized Water, Cetyl Alcohol, PEG-150 Distearate, Isopropyl Myristate, Glycerin, Sodium Lauryl Sulfate, Polysorbate-20, Triethanolamine, Acrylates Copolymer, Propylene Glycol, Methyl Paraben, Propyl Paraben, Diazolidinyl Urea, FD and C Blue 1, D and C Yellow 5

Medrox

(medroxcin)

Pain Relief Ointment

For Questions or Comments
Please Email:
info@ipnarx.com

120gm (4 fl oz)

Medrox

MEDROX  
methyl salicylate, menthol, capsaicin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-095(NDC:45861-001)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-095-02120 g in 1 BOTTLE
2NDC:52959-095-6060 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/09/2011
Labeler - H.J. Harkins Company, Inc. (147681894)
Registrant - H.J. Harkins Company, Inc. (147681894)
Establishment
NameAddressID/FEIBusiness Operations
H.J. Harkins Company, Inc.147681894repack, relabel

Revised: 1/2012
Document Id: 0806c64e-e77d-4aa8-ad24-67714b5c5148
Set id: 7031eb87-4378-463b-9b00-aa8fdc3dc770
Version: 3
Effective Time: 20120119
 
H.J. Harkins Company, Inc.