MENTHOZEN HYDROGEL- menthol, capsaicin patch 
Proficient Rx LP

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Menthozen Hydrogel Patch

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:

71205-334-30

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

MENTHOZEN HYDROGEL 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-334(NDC:71574-601)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM40 mg  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-334-055 in 1 POUCH11/20/2020
11 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:71205-334-1515 in 1 POUCH09/01/2019
21 g in 1 PATCH; Type 0: Not a Combination Product
3NDC:71205-334-3030 in 1 POUCH09/01/2019
31 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/01/2019
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-334) , RELABEL(71205-334)

Revised: 12/2023
Document Id: 1cdc9d1f-d8eb-40e4-99e6-286c7dbfb986
Set id: 85a7809e-c43f-4138-a85b-44e1b586def5
Version: 6
Effective Time: 20231201
 
Proficient Rx LP