Label: PAINAZIN CP- capsaicin spray

  • NDC Code(s): 64058-117-14
  • 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 07/11

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

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  • Purpose

    Pain Relieving

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  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • sprains
    • bruises
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  • Warnings

    For external use only.

    • do not apply to wounds or damaged skin
    • do not bandage tightly
    • do not use with heating pad, pack, wrap, hot water bottle or any heating element

    When using this product do not get into eyes

    • avoid contact with other mucous membranes

    Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or 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
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  • PREGNANCY OR BREAST FEEDING

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

    • Children under 12 years of age consult a physician
    • To avoid inhaling product, hold bottle close to skin while spraying
    • 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
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  • 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 initial 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.
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  • Inactive ingredients

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

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  • Questions or comments?

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

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  • PRINCIPAL DISPLAY PANEL - 118mL Bottle Label

    NDC 64058-117-14

    Painazin-CP

    Therapeutic
    Pain Relieving Spray
    with Emu Oil, Glucosamine & MSM

    Penetrating Pain Relief

    • Arthritis
    • Simple Backache
    • Strains
    • Sprains

    Greaseless • Odorless • Stainless

    4 FL OZ (118mL)

    PRINCIPAL DISPLAY PANEL - 118mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    PAINAZIN CP 
    capsaicin spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64058-117
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Capsaicin (Capsaicin) Capsaicin 0.00025 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    GLYCERIN  
    DIMETHYL SULFONE  
    ALOE VERA LEAF  
    MEDICAGO SATIVA 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:64058-117-14 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/27/2011
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    Name Address ID/FEI Business Operations
    Concept Laboratories, Inc. 962282612 MANUFACTURE
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