PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]

PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]
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NDC 64058-118-14
Set ID d71b0793-0e69-4249-ac4b-d819fe2882aa
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

    Active ingredientPurpose
    Capsicum Oleoresin 0.0625%Pain
    (Containing Capsaicin 0.025%)Relieving
  • Uses

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

    • simple backache
    • arthritis
    • strains
    • sprains
  • Warnings

    For external use only.

    • do not apply to wounds or damaged skin

    When using this product do not get into eyes

    • do not bandage tightly
    • do not use with heating pad, wrap, hot water bottle or any heating element.

    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
  • 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
    • 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.
  • 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.

  • Questions or comments?

    Call toll-free 1-888-373-8831

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Concept Laboratories, Inc.
    Chicago, IL 60642 (USA)
    #CL10010

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    Pure Relief

    Penetrating
    Pain Relief Spray
    with Capsaicin

    Temporary relieves
    joint & arthritis pain in

    • Hips
    • Knees & Elbows
    • Hands & Feet
    • And more

    4 FL OZ (118mL)

    Principal Display Panel - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PURE RELIEF   PENETRATING PAIN RELIEF
    capsaicin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.0295 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALFALFA 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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64058-118-14118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/06/2013
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Concept Laboratories, Inc.962282612MANUFACTURE(64058-118)

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