Label: NUDROXICIN- menthol, capsaicin patch

  • NDC Code(s): 70859-022-15
  • Packager: NuCare Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 11, 2019

If you are a consumer or patient please visit this version.

  • DRUG FACTS:

  • ACTIVE INGREDIENTS:

    Menthol 5.00%

    Capsaicin 0.0375%

    Analgesic/Counterirritant

    External Analgesic

  • USES:

    For the temporary relief of minor aches and pains of the muscles and joints
    associated with simple backache, arthritis, sprains, bruises and strains.

  • WARNING:

    • For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
    • Do not cover with bandage.

    Do not use 

    • on wounds or damaged skin
    • Do not use in combination with and other external analgesic products.
    • Avoid contact with eyes and mucous membranes.
    • 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.

    • Consult physician for children under 12.
    • Do not use if you are allergic to Menthol.

    Stop use and ask a doctor if

    • conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
    • or Rash, itching or excessive skin irritation occurs.
  • DIRECTIONS:

    • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.
    • Children under 12 years, consult physician before use.
    • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • wash hands with soap after applying patch
    • Reseal pouch containing unused patched
  • OTHER INGREDIENTS

    Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben.

  • Package Labeling:

    Box

  • INGREDIENTS AND APPEARANCE
    NUDROXICIN 
    menthol, capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70859-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.375 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70859-022-1515 in 1 CARTON08/16/2017
    110 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/16/2017
    Labeler - NuCare Pharmaceuticals, Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals, Inc.010632300repack(70859-022) , relabel(70859-022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(70859-022)