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MEDROX (methyl salicylate, menthol, capsaicin ) ointment
[Pharmaceutica North America]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

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


  • For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.

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

PRINCIPAL DISPLAY PANEL

Medrox

(medroxcin)

  • Effective
  • Soothing
  • Long Lasting
Pain Relief Ointment

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

120gm (4 fl oz)

Medrox

INGREDIENTS & APPEARANCE

MEDROX 
methyl salicylate, menthol, capsaicin ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45861-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE20 g  in 100 g
MENTHOL (MENTHOL) MENTHOL5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CETYL ALCOHOL 
PEG-150 DISTEARATE 
ISOPROPYL MYRISTATE 
GLYCERIN 
SODIUM LAURYL SULFATE 
POLYSORBATE 20 
TROLAMINE 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
DIAZOLIDINYL UREA 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45861-001-6060 g in 1 BOTTLE
2NDC:45861-001-01120 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/09/2011
Labeler - Pharmaceutica North America (962739699)

Revised: 2/2011
 
Pharmaceutica North America