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Name:Medrox
Manufacturer:Pharmaceutica North America
Category:Over-the-counter (OTC) Marketed Drugs


Medrox (Medroxin)

MEDROX  - methyl salicylate, menthol and capsaicin ointment 
Pharmaceutica North America

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


  • 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

Medrox

(medroxcin)

  • Effective
  • Soothing
  • Long Lasting
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 Type HUMAN OTC DRUG Item Code (Source) NDC:45861-001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 20 g  in 100 g
MENTHOL (MENTHOL) MENTHOL 5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.0375 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
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  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45861-001-60 60 g in 1 BOTTLE None
2 NDC:45861-001-01 120 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/09/2011

Labeler - Pharmaceutica North America (962739699)

Revised: 02/2011 Pharmaceutica North America



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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