FAST ARTHRITIS AID PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]

FAST ARTHRITIS AID PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]
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NDC 64058-413-42, 64058-413-44
Set ID 53a4935b-c7a3-41ce-b14a-983985aaa9a8
Category HUMAN OTC DRUG LABEL
Packager Concept Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Capsicum Oleoresin 0.0625% (contains Capsaicin 0.025%)

  • Purpose

    Pain Relieving

  • INDICATIONS & USAGE

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

  • 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

    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

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

  • 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

  • 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.

  • Inactive ingredients

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

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Manufactured by Concept Laboratories, Inc.
    Chicago, IL 60642 www.conceptlabs.org
    #BG-CL9734

  • PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

    NDC 64058-413-42

    Immediate Warming Relief

    For Arthritis Joint and Muscle Pain

    Fast Arthritis Aid

    Pain Relieving Gel

    2 oz (57g)

    Principal Display Panel - 57 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    FAST ARTHRITIS AID   PAIN RELIEVING
    capsaicin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-413
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.01425 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDICAGO SATIVA LEAF (UNII: HY3L927V6M)  
    CYMBOPOGON SCHOENANTHUS LEAF (UNII: XF54B1Z2HF)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    GINKGO (UNII: 19FUJ2C58T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EMU OIL (UNII: 344821WD61)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64058-413-4257 g in 1 BOTTLE
    2NDC:64058-413-44113 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34808/05/2011
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Concept Laboratories, Inc.962282612MANUFACTURE(64058-413)

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