Label: MIRACLE PLUS OVERNIGHT PAIN RELIEVING- capsaicin gel

  • 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 December 3, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

  • Purpose

    Pain Relieving

  • 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 HCI, 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 #BG-MP9874

  • PRINCIPAL DISPLAY PANEL - 113 g Bottle Label

    MIRACLE®
    PLUS

    OVERNIGHT

    PAIN RELIEVING
    GEL

    odor-free
    pain relief

    IMMEDIATE
    RELIEF

    • Warming, soothing pain relief
    • Stainless, greaseless formula
    • Temporarily relieves backaches,
      muscle aches, joint pain, and arthritis

    4 OZ. (113 g)

    Principal Display Panel - 113 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    MIRACLE PLUS OVERNIGHT   PAIN RELIEVING
    capsaicin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-155
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.02825 g  in 113 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)  
    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)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64058-155-44113 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:64058-155-4257 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34811/20/2014
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Concept Laboratories, Inc.962282612MANUFACTURE(64058-155)
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