JOINTFLEX (CAMPHOR) CREAM [STRIDES PHARMA INC]

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JOINTFLEX (CAMPHOR) CREAM [STRIDES PHARMA INC]
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NDC 59556-813-45
Set ID f9ef2e9e-8b09-4797-8a14-03cca5bd1059
Category HUMAN OTC DRUG LABEL
Packager Strides Pharma Inc
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Camphor (3.1%)

  • Purpose

    Counterirritant

  • Uses

    Temporarily relieves minor pain associated with:

    • minor arthritis pain 
    • simple backache
    • muscle sprains and strains
    • simple backache
    • bruises 
    • cramps
  • Warnings

    For external use only

  • Do not use if

    • skin is irritated or damaged
    • excessive irritation develops
    • 12 years of age or under
  • When using this product

    • use only as directed
    • avoid contact with the eyes and mucous membranes
    • do not apply to wounds, damaged, broken or irritated skin
    • do not bandage tightly or use a heating pad
    • do not swallow. If swallowed, contact a physician or contact a poison control center immediately
  • Stop use and ask doctor if

    • condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness develops
  • If pregnant or breast feeding,

    ask a health professional before use

  • Keep out of reach of children.

  • Directions

    • cleanse, rinse and dry skin prior to application
    • apply generously to painful muscles and joints, gently massaging until the JointFlex Pain Relieving Cream disappears.
    • repeat as necessary but no more than 4 times a day
    • for optimum benefit, use daily for at least two weeks and continue to use daily thereafter.
  • Other

    • store at room temperature with the cap closed
    • notice: Because this product contains natural nutrients, color may vary
  • Inactive Ingredients

    Acetylated Lanolin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Vera, C12-15 Alkyl Benzoate, Chondroitin Sulfate, Diazolidinyl Urea, Dimethicone, Dimethiconol Stearate, Disodium EDTA, dl Panthenol, Glucosamine Sulfate, Glycerin, Glycerol Stearate, Glycosaminoglycans, Hydroxylated Lanolin, Hydroxpropylene Methycellulose, Idopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Tocopheryl Acetate (Vitamin E).

  • Questions or comments?

    Call toll free 1-888-464-3336.

    Strides Pharma Inc.

    East Brunswick, NJ 08816

    www.jointflex.com

  • PRINCIPAL DISPLAY PANEL - 114 g Tube Carton

    Immediate and
    Long Term Improving
    Pain Relief1

    Joint
    Flex®
    Out™
    Pain

    Arthritis
    Pain
    Relief
    Cream

    Penetrates
    Deeply

    Relieves back,
    knee, neck
    and shoulder pain

    with Glucosamine
    & Chondroitin
    Sulfate for Skin
    Conditioning

    NET WT
    4 OZ (114g)

    EXCLUSIVE
    FUSOME®
    SKIN DELIVERY SYSTEM

    PRINCIPAL DISPLAY PANEL - 114 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    JOINTFLEX 
    camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-813
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.58 g  in 114 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ACETYLATED LANOLIN (UNII: 2X654GD19H)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYLATED LANOLIN (UNII: EOI0B9800C)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHARK CARTILAGE (UNII: D2YCN1I522)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-813-451 in 1 CARTON04/16/2010
    1114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/16/2010
    Labeler - Strides Pharma Inc (078868278)
    Establishment
    NameAddressID/FEIBusiness Operations
    SmartScience Laboratories Inc035907919manufacture(59556-813) , pack(59556-813)
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