Label: JOINTFLEX ICE - menthol lotion

  • NDC Code(s): 16864-002-01
  • Packager: MOBERG PHARMA NORTH AMERICA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • Active Ingredients

    Natural Menthol, USP (8.5%)

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  • Purpose

    Topical Analgesic

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  • Uses:

    Provides temporary pain relief of:

    • Minor arthritis pain
    • Muscle sprains
    • Bruises
    • Simple backaches
    • Muscle strains
    • Cramps
    • Tendonitis
    • Bursitis
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  • Warnings:

    For external use only

    • Flammable: Keep away from excessive heat or open flame
    • Ask a doctor before use if you have sensitive skin
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  • When using this product:

    • Do not use on wounds or irritated skin
    • Do not bandage tightly or use with a heating pad
    • Wash hands after use with cool water
    • Avoid contact with eyes or mucas membranes
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  • If pregnant or breast feeding,

    ask a health professional before use

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  • Keep out of reach of children.

    If accidentally swallowed, contact a doctor or poison control center immediately

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  • Stop use and ask a doctor

    if condition worsens or if pain persists for more than 7 days, or clears up, then reoccurs within a few days, or if excessive skin irritation occurs.

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  • Directions:

    Use only as directed

    • Do not use on children under 12 years of age.
    • Roll onto affected area no more than four times daily
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  • Inactive Ingredients:

    Aloe Barbadensis Leaf Extract, Arnica Montana Extract, Boswellia Serrata Extract, Camphor, Carbomer, Chondroitin Sulfate, Glucosamine Sulfate, Glycerin, Ilex Paraguarensis Extract, Isopropyl Alcohol, Methyl Paraben, Methylsulfonylmethane, Peppermint Oil, Polysorbate 20, Propylene Glycol, Triethanolamine, Purified Water

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  • Other Information:

    Store in a cool dry place with the cap tightly closed.

    Note: This product contains natural ingredients, color may vary.

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  • Questions or comments?

    Call toll free 1-888-464-3336

    www.jointflex.com

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  • Principal Display Panel

    Cooling Pain Relief with Natural Menthol

    JointFlex® -OUT PAIN™ ICE

    No Mess Roll-On

    Pain Relieving Lotion

    Stay Mobile and Flexible!

    Also Contains Ilex · Arnica · Boswellia · Peppermint Oil

    MADE IN THE USA

    3 FL OZ (88ML)

    Convenient

    No Mess Roll-On

    Take It With You Wherever You Go!

    Actual size of product is larger than shown.

    GUARANTEED PERFORMANCE OR YOU MONEY BACK!

    Deep, Penerating Pain Relief Pain Relief!

    2x Dual Action Formula

    COOLING PAIN RELIEF

    Massages Joints & Muscles

    Stay Mobile and Flexible

    ✓ Greaseless✓ Stainless
    ✓ Fresh Scent
    ✓ Fast Acting

    Money Back Guarantee

    "If you use JointFlex as directed and are not completely amazed with the pain relief you receive, simply return the bottle (even if it's empty) and the cash register receipt to the address on this box for a full refund. No questions asked."

    ®TM ©2012, Dist. by Moberg Pharma North America LLC
    7 E. Frederick Place, Suite 100
    Cedar Knolls, NJ 07927
    All Rights Reserved. Made in USA.

    ALT-JF3OZ5C

    Joint Flex Ice Box

    Cooling Pain Relief Formula

    In a Soothing Base of Arnica, ILEX, MSM & Boswellia

    JointFlex® -OUT PAIN™ ICE

    No Mess Roll-On

    Pain Relieving Lotion

    Targeted Pain Relief: back, neck, shoulders, and muscle pain

    3 FL OZ (88ML)

    TM ©2010, Dist. by Moberg Pharma North America LLC, 7 E. Frederick Place, Suite 100, Cedar Knolls, NJ 07927
    FDA Drug Registration No. NDC 16864-002. All Rights Reserved. Made in USA.

    ALT-JF3OZ4B

    Joint Flex Ice Label
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  • INGREDIENTS AND APPEARANCE
    JOINTFLEX ICE  
    natural menthol lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:16864-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (Menthol) Menthol 8.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    ARNICA MONTANA  
    CARBOMER 934  
    GLUCOSAMINE SULFATE  
    GLYCERIN  
    ISOPROPYL ALCOHOL  
    METHYLPARABEN  
    PEPPERMINT OIL  
    POLYSORBATE 20  
    PROPYLENE GLYCOL  
    TROLAMINE  
    WATER  
    INDIAN FRANKINCENSE  
    CHONDROITIN SULFATE (BOVINE)  
    ILEX PARAGUARIENSIS LEAF  
    Dimethyl Sulfone  
    Camphor (synthetic)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16864-002-01 88 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 04/06/2010
    Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)
    Establishment
    Name Address ID/FEI Business Operations
    Smart Science 035907919 MANUFACTURE(16864-002)
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