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MEDROX by Unit Dose Services

Dosage form: patch
Ingredients: MENTHOL 5g in 100g, CAPSAICIN 0.0375g in 100g
Labeler: Unit Dose Services
NDC Code: 50436-9991

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


Menthol                     5.00%

Capsaicin                  0.0375%

PURPOSE

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.
  • Consult physician for  children under 12.
  • Do not use if you are allergic to 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
  • Or rash, itching or excessive skin irritation occurs.

KEEP OUT OF REACH OF CHILDREN

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


Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodiumm Salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben.

MEDROX (MENTHOL, CAPSAICIN ) PATCH
MEDROX  
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-9991(NDC:45861-014)
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
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
POLYSORBATE 80 
ALOE VERA LEAF 
EDETATE DISODIUM 
DIAZOLIDINYL UREA 
METHYLPARABEN 
IODOPROPYNYL BUTYLCARBAMATE 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:50436-9991-15 g in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/13/2012
Labeler - Unit Dose Services (831995316)
Registrant - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIOperations
Unit Dose Services831995316REPACK(50436-9991)

Revised: 06/2012
 
Unit Dose Services

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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