MENTHOZEN HYDROGEL- menthol, capsaicin patch

Menthozen Hydrogel by

Drug Labeling and Warnings

Menthozen Hydrogel by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

MENTHOZEN HYDROGEL 
menthol, capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-334(NDC:71574-601)
Route of Administration	TOPICAL

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

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: 71205-334-15	15 in 1 POUCH	09/01/2019
1		1 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 71205-334-30	30 in 1 POUCH	09/01/2019
2		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2019

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(71205-334) , RELABEL(71205-334)