Label: JOINTFLEX ICE - natural 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 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 31, 2016

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
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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

    New Look!
    Same Trusted Formula

    Cools & Soothes Aching Joints and Muscles

    JointFlex-OUT PAIN™ ICE

    Pain Relieving Lotion

    with Menthol 8.5%

    Supports Mobility

    No Mess Roll-on

    Also Contains: Arnica, Ilex and Boswellia

    NET WT 3 OZ (88 mL)

    Fresh Scent

    Actual size of product is larger than shown.

    Money Back Guarantee

    If you use JointFlex Ice 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.

    Experience Cooling Pain Relief

    JointFlex® Ice provides Cooling Pain Relief for aching joints and muscles in a
    Fast Acting, Greaseless, Fresh Scent formula.

    Also from the makers of JointFlex®
    For Strong Headache Relief and Effective, yet Gentle Pain Relief, try Vanquish®*

    *Sold separately

    Questions or comments?
    Call toll free 1-888-464-3336

    *TM ©2014 Dist by
    Moberg Pharma North America LLC
    7 E Frederick Place, Suite 100
    Cedar Knolls, NJ 07927
    All Rights Reserved Made in USA

    ALT-JF3OZ6C

    Joint Flex Ice Carton
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  • INGREDIENTS AND APPEARANCE
    JOINTFLEX ICE  
    natural menthol lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16864-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 8.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Arnica Montana (UNII: O80TY208ZW)  
    Indian Frankincense (UNII: 4PW41QCO2M)  
    Camphor (synthetic) (UNII: 5TJD82A1ET)  
    Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Chondroitin Sulfate (shark) (UNII: 2ZAJ1K50XH)  
    Glucosamine Sulfate Potassium Chloride (UNII: 15VQ11I66N)  
    Glycerin (UNII: PDC6A3C0OX)  
    Ilex Paraguariensis Leaf (UNII: 1Q953B4O4F)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Trolamine (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16864-002-01 88 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/06/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 04/06/2010
    Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)
    Establishment
    Name Address ID/FEI Business Operations
    SmartScience Laboratories, Inc. 035907919 manufacture(16864-002)
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