MEDROX- menthol, capsaicin patch 
Preferred Pharmaceuticals, Inc.

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.

HOW SUPPLIED

5 Patches – 68788-6755-5

30 Patches – 68788-6755-3


Relabeled by Preferred Pharmaceuticals, Inc.

MEDROX Patch

Medrox Patch
MEDROX 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6755(NDC:45861-014)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-6755-55 in 1 BOX07/27/2012
110 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:68788-6755-330 in 1 BAG07/27/2012
210 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/27/2012
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-6755)

Revised: 12/2017
Document Id: 63eea2b9-bea1-4347-a6ed-222d5f749d86
Set id: 5b171000-a3d7-4adf-817f-1eba14773e0a
Version: 4
Effective Time: 20171220
 
Preferred Pharmaceuticals, Inc.