CMX TOPICAL PAIN- menthol, capsaicin patch

CMX Topical Pain by

Drug Labeling and Warnings

CMX Topical Pain by is a Otc medication manufactured, distributed, or labeled by Unik Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

CMX TOPICAL PAIN 
menthol, capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69889-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0375 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69889-027-15	15 in 1 BOX	09/15/2016
1		8 g in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/15/2016

Labeler - Unik Pharmaceuticals, Inc (079835464)