Label: FAST ARTHRITIS AID- capsicum oleoresin 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 May 22, 2015

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

View All Sections
  • 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

    • arthritis
    • strains
    • sprains
  • Warnings

    For external use only.

    • do not apply to wounds or damaged skin
    • do not bandage tightly

    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

    • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
    • Children under 12 years of age consult a physician
    • Apply liberally 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
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    Manufactured by Concept Laboratories, Inc.
    Chicago, IL 60642 www.conceptlabs.org

  • PRINCIPAL DISPLAY PANEL - 244g Bottle Label

    NDC 64058-213-18

    Immediate
    Warming Relief
    for Arthritis Joint &
    Muscle Pain

    FAST™
    ARTHRITIS
    AID

    PAIN
    RELIEVING
    GEL

    NET WT 8.6 OZ. (244g)

    Principal Display Panel - 244g Bottle Label
  • INGREDIENTS AND APPEARANCE
    FAST ARTHRITIS AID 
    capsicum oleoresin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsicum Oleoresin (UNII: UW86K581WY) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.061 g  in 244 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:64058-213-18244 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 FINALpart34804/17/2015
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Concept Laboratories, Inc.962282612MANUFACTURE(64058-213)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!