Active Ingredients
Menthol 5.00%
Capsaicin 0.0375%
Mendex
FDA Label NDC 69329-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Patchwerx Labs, Inc for the product Mendex (NDC 69329-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children, directions, other ingredients, mendex 25 patches (69329-013-25), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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)
* Please review the disclaimer below.
