MENTHOZEN HYDROGEL PATCH- menthol,capsaicin patch

Menthozen Hydrogel Patch by

Drug Labeling and Warnings

Menthozen Hydrogel Patch by is a Otc medication manufactured, distributed, or labeled by Beijing HKKY Medical Tech. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

ACTIVE INGREDIENTS:

Menthol  4.00%

Capsaicin  0.03%

External Analgesic

External Analgesic

USES:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arhritis, 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 withy 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 irrigation 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:

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 containing unused patches.

OTHER INFORMATION:

Store below 25 degree 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 Disodum Salt

Package Labeling:

INGREDIENTS AND APPEARANCE

MENTHOZEN HYDROGEL PATCH 
menthol,capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71073-101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71073-101-45	5 in 1 POUCH	07/01/2019
1		40 mL in 1 PATCH; 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	07/01/2019

Labeler - Beijing HKKY Medical Tech. Co., Ltd. (544434817)

Establishment
Name	Address	ID/FEI	Business Operations
Beijing HKKY Medical Tech. Co., Ltd.		544434817	manufacture(71073-101)