CMX TOPICAL PAIN- menthol, capsaicin patch 
Unik Pharmaceuticals, Inc

----------

CMX Topical Pain Patch

DRUG FACTS:

Active Ingredient:

Menthol 5.00%

Capsaicin 0.0375%

Topical Analgesic

External Analgesic

Uses:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings:

• For external use only. Use only as directed.
• Avoid contact with eyes and mucous membranes.
• Do not apply to open wounds or damaged skin.

Do not use

• in combination with any external heat source.
• Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar
device or garment.

Keep out of reach of children.

• Consult physician for children under 12.
• Do not use if allergic to Menthol.

Stop use and consult physician

• if symptoms worsen or persist for more than 7 days.

• Stop use if itching to excessive skin irritation occurs.

If pregnant or breast feeding

• contact physician prior to use.

Directions:

Adults and children 12-years and over: Apply to affected area; change patch 1-2 times daily.
Children under 12, consult a physician before use.
How to Apply:
• Clean and dry affected area.
• Remove patch from backing and apply directly to area of pain.
• Do not apply to affected area more than three times daily.
• Use only on patch at a time.
• Wash hands with soap and water immediately after application.
• Reseal pouch containing unused patches.

Other Ingredients:

Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Polysorbate-80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodium Salt, Diazolidinyl Urea, Methyl Paraben, Iodopropynyl Butylcarbamate, Propyl Paraben.

Store at room temperature.

Avoid direct sunlight

Package Labeling:

Patch

CMX TOPICAL PAIN 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69889-027
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) 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:69889-027-1515 in 1 BOX09/15/201601/04/2017
18 g in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/15/201601/04/2017
Labeler - Unik Pharmaceuticals, Inc (079835464)

Revised: 10/2023
 
Unik Pharmaceuticals, Inc