Label: ARTHRITAZIN PAIN RELIEVING- capsaicin gel
ARTHRITAZIN PAIN RELIEVING EZ- capsaicin gel

  • NDC Code(s): 64058-123-41, 64058-813-49, 64058-913-13
  • Packager: Concept Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    Capsicum Oleoresin 0.0625%
    (Containing Capsaicin 0.025%)

    Close
  • Purpose

    Pain Relieving

    Close
  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains sprains

    Close
  • Warnings

    For external use only. do not apply to wounds or damaged skin do not bandage tightly do not use with heating pad, wrap, hot water bottle or any heating element.

    When using this product do not get into eyes

    avoid contact with other mucous membranes

    Stop use and ask a doctor if condition worsens if symptoms persist for more than 7 days clear up and occur again within a few days

    Keep out of reach of children.

    if swallowed, get medical help or contact a Poison Control center right away

    if pregnant or nursing, seek the advice of a health professional before using

    Close
  • Directions

    Children under 12 years of age consult a physician Apply a thin layer to affected area not more than 3 to 4 times daily Gently massage into the skin until fully absorbed Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

    Close
  • Other information

    It is recommended to test for skin sensitivity prior to use. Apply product to a small area, follow the directions and wait 24 hours. Proceed with application if no adverse reaction. A burning sensation may occur upon inital application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil. If applying product to hands, wait 30 minutes before washing. Avoid water, heat, or direct sunlight while using product. If wearing contact lenses, insert prior to application and avoid touching them after applying product. If eye contact occurs, flush immediately with water.

    Close
  • Inactive ingredients

    Water (Aqua), Glycerin, PEG-75 Lanolin, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Triethanolamine, Polysorbate 20, Celosia Argentea Seed Extract, Ginkgo Biloba Extract, Panax Ginseng Root Extract, Medicago Sativa (Alfalfa) Extract, Cymbopogon Schoenanthus Extract, Emu Oil, Dimethyl Sulfone, Tocopheryl Acetate, Glucosamine HCl, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben.

    Close
  • Questions or comments?

    Call 1-888-373-8831 or visit www.conceptlabs.org

    Close
  • SPL UNCLASSIFIED SECTION

    Manufactured by: #CL9775
    Concept Laboratories, Inc.
    Chicago, IL 60642 (USA) NDC 64058-813-49

    Close
  • PRINCIPAL DISPLAY PANEL - 255 g Bottle Label

    ArthritazinTM
    Pain Relieving Gel
    Moisturizing Vitamin E
    Warming relief from arthritis pain
    NET WT 9 OZ (255 g)

    PRINCIPAL DISPLAY PANEL - 255 g Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 113 g Bottle Label

    ArthritazinTM
    EZ Pain Relief Gel
    Soothing Massaging Applicator
    Temporary relief from arthritis pain
    NET WT 4 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 255 g Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

    ArthritazinTM
    Pain Relieving Gel
    Eazy to use travel size
    Relief from arthritis pain
    NET WT 3 OZ (85 g)

    PRINCIPAL DISPLAY PANEL - 255 g Bottle Label
    Close
  • INGREDIENTS AND APPEARANCE
    ARTHRITAZIN PAIN RELIEVING 
    capsaicin gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64058-913
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Capsaicin (Capsaicin) Capsaicin 0.02125 g  in 85 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Glycerin  
    PEG-75 LANOLIN  
    DIMETHYL SULFONE  
    ALOE VERA LEAF  
    ALFALFA LEAF  
    CYMBOPOGON SCHOENANTHUS LEAF  
    GLUCOSAMINE HYDROCHLORIDE  
    GINKGO  
    POLYSORBATE 20  
    EMU OIL  
    DMDM HYDANTOIN  
    PROPYLENE GLYCOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64058-913-13 85 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 01/10/2013
    ARTHRITAZIN PAIN RELIEVING   EZ
    capsaicin gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64058-123
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Capsaicin (Capsaicin) Capsaicin 0.02825 g  in 113 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Glycerin  
    PEG-75 LANOLIN  
    DIMETHYL SULFONE  
    ALOE VERA LEAF  
    ALFALFA LEAF  
    CYMBOPOGON SCHOENANTHUS LEAF  
    GLUCOSAMINE HYDROCHLORIDE  
    GINKGO  
    POLYSORBATE 20  
    EMU OIL  
    DMDM HYDANTOIN  
    PROPYLENE GLYCOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64058-123-41 113 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 02/07/2013
    ARTHRITAZIN PAIN RELIEVING 
    capsaicin gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64058-813
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Capsaicin (Capsaicin) Capsaicin 0.06375 g  in 255 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Glycerin  
    PEG-75 LANOLIN  
    DIMETHYL SULFONE  
    ALOE VERA LEAF  
    ALFALFA LEAF  
    CYMBOPOGON SCHOENANTHUS LEAF  
    GLUCOSAMINE HYDROCHLORIDE  
    GINKGO  
    POLYSORBATE 20  
    EMU OIL  
    DMDM HYDANTOIN  
    PROPYLENE GLYCOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64058-813-49 255 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 01/17/2013
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    Name Address ID/FEI Business Operations
    Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-913, 64058-123, 64058-813)
    Close