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Medrox

Pharmaceutica North America

Medrox Patch


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Medrox

METHYL SALICYLATE, MENTHOL, CAPSAICIN PATCH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45861-004
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
methyl salicylate METHYL SALICYLATE 20 g
MENTHOL 5 g
capsaicin CAPSAICIN 0.0375 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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 PATCH
2 NDC:45861-004-05 5 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2011-05-25


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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