DRUG FACTS:

ACTIVE INGREDIENTS:

Menthol 4.00%

Capsaician 0.03%

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.

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 or 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 dily.

Children under 12, consult a physician before use.

: How to Apply

Remove patch from backing and apply directly to area of pain.

Do not apply to affected area more than three times daily.

Use only one patch at a time.

Wash hands with soap and water immediately after application.

Reseal pouch containg unused patches.

OTHER INFORMATION:

Store below 25 degrees Celsius. Avoid direct sunlight.

INACTIVE INGREDIENTS:

Aqua (Deionized Water), Sodium Polyacrylate, Glycerol, D-Glucitrol, Sodium Cellulose Glycolate, Polysorbate-80, Lemon Oil, Aluminum Glycinate, Methylparaben, EDTA Disodium Salt

Package Labeling:

Label

MENTHOZEN HYDROGEL
menthol, capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71574-601
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LEMON OIL (UNII: I9GRO824LL)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71574-601-05	5 in 1 POUCH	07/01/2019
1		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	07/01/2019

Labeler - Village Pharma LLC (080749749)

Menthozen Hydrogel Patch