MENDEX- menthol, capsaicin patch 
Patchwerx Labs, 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.

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MENDEX 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


KEEP OUT OF REACH OF CHILDREN

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.

MENDEX 25 Patches (69329-013-25)

mendex label small.jpg

MENDEX 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69329-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.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:69329-013-2525 in 1 BOX
110 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/10/2014
Labeler - Patchwerx Labs, Inc (079584480)

Revised: 11/2014
Document Id: 07eec701-f57a-7394-e054-00144ff88e88
Set id: 07eec701-f579-7394-e054-00144ff88e88
Version: 1
Effective Time: 20141115
 
Patchwerx Labs, Inc