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Medrox by Pharmaceutica North America

Dosage form: patch
Ingredients: METHYL SALICYLATE 20g in 100g, MENTHOL 5g in 100g, CAPSAICIN 0.0375g in 100g
Labeler: Pharmaceutica North America
NDC Code: 45861-004

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 Patch

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


  • Adults and children 12 years and over apply to affected area: change patch 1 to 2 times daily.
  • Children under 12 years, consult physician before use
  • How to apply:
  • Clean and dry affected area
  • Cut open pouch and remove patch
  • Remove protective film and apply directly to area of pain
  • Apply to affected area not more than 3 times daily
  • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches

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

Product Label

Medrox

Manufactured For:  Pharmaceutica North America

Glendale, CA 91204

For Questions or Comments please call 877-328-2592


MEDROX 
methyl salicylate, menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45861-004
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 Description
1NDC:45861-004-055 PATCH in 1 BOX
110 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/25/2011
Labeler - Pharmaceutica North America (962739699)

 
Pharmaceutica North America

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Medically reviewed on Dec 28, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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