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Medrox by Pharmaceutica North America, Inc.

Medically reviewed on December 1, 2017

Dosage form: patch
Ingredients: MENTHOL 5g in 100g, CAPSAICIN 0.0375g in 100g, METHYL SALICYLATE 5g in 100g
Labeler: Pharmaceutica North America, Inc.
NDC Code: 45861-009

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 5% analgesic/counterirritant

menthol 5% analgesic/counterirritant

capsaicin 0.0375% external analgesic

Inactive ingredients

water, glycerine, sodium polyacrylate, polysorbate 80, alo barbadesis leaf (aloe vera gel) juice, EDTA disodium salt, diazolidinyl urea, methylparaben, idopropynl butylcabamate, propylparaben.

Keep out of reach of children

Keep out of reach of children. consult physician for children under 12.

Administration

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 are not move than 3 times daily

    wash hands with soap after applying patch

    reseal pouch containing unused patches

Use

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

Purpose

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.

do not use if you are allergic to methyl salicylate or menthol.

stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.

if rash, itching or excessive skin irritations occurs.

Storage

store below 25 degrees, avoid direct sunlight.

Package display

MEDROX 
menthol, capsaicin, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45861-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.0375 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water 
GLYCERIN 
ALOE VERA LEAF 
DIAZOLIDINYL UREA 
DISODIUM SULFOSALICYLATE 
IODOPROPYNYL BUTYLCARBAMATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM POLYACRYLATE (8000 MW) 
Packaging
#Item CodePackage Description
1NDC:45861-009-055 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/27/2011
Labeler - Pharmaceutica North America, Inc. (962739699)
Registrant - Pharmaceutica North America, Inc. (962739699)

 
Pharmaceutica North America, Inc.

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Further information

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

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