Label: MENTHOZEN HYDROGEL- menthol, capsaicin patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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