Label: MUSCLE AND JOINT PAIN RELIEF GEL- menthol, eucalyptus globulus leaf oil gel

  • NDC Code(s): 61383-701-01, 61383-701-96
  • Packager: Dimensional Merchandising Inc.
  • Category: HUMAN OTC DRUG LABEL

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 November 16, 2016

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  • Drug Facts

  • Active Ingredients

    Menthol 5.0%

    Eucalyptus Globulus Leaf Oil 3.25%

  • Purpose

    Topical Analgesic

  • Uses:

    Temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises and sprains.

  • Warnings:

    For external use only.

    Do Not Use: On wounds or damaged skin, with a heating pad, or on a child under 12 years of age with arthritis-like conditions.

    Ask a Doctor Before Use If You Have: Redness over the affected area.

    When Using This Product: Avoid contact with eyes or mucous membranes; do not bandage tightly.

    Stop Use and Ask Doctor If: Condition worsens or symptoms persist for more than 7 days, if symptoms clear up and occur again within a few days, or if redness is present or excessive skin irritation develops.

    CAUTION: Keep away from eyes. Wash hands and fingers thoroughly.

  • Keep Out of Reach of Children:

     In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

  • Directions:

    Use only as directed. After use, wipe off applicator head and replace protective cap. Clean outside with damp cloth or paper towel. Do not rinse under or immerse in water.

    Adults and children 12 years of Age and older: apply to affected area not more than 3 to 4 times daily.

    Children Under 12 years of Age: consult a doctor.

  • STORAGE AND HANDLING

    Other Information: Store between 20 and 25 °C (68 and 77 °F)

  • Other Ingredients:

    Water, Alcohol Denatured, Glycerin, Piper Methysticum Leaf/Root/Stem Extract, Calendula Officinalis Flower Extract, Arnica Montana Flower Extract, Carbomer, Butylene Glycol, Propylene Glycol, Polysorbate 20, Chlorphenesin, Sodium Hydroxide, Sodium Benzoate, Potassium Sorbate.

  • SPL UNCLASSIFIED SECTION

    NatureWell™ CLINICAL

    WITH KAVA EXTRACT

    MUSCLE STRAINS

    JOINT PAIN

    STRAINS AND CRAMPS

    TEMPORARY PAIN RELIEF • SOOTHES ACHES & PAINS • QUICK VANISHING ODOR

    FAST-ACTING • NON-GREASY • QUICK-DRY FORMULA 

    HANDS FREE ROLLER BALL APPLICATION

    MESS-FREE MASSAGING APPLICATOR

    No Parabens • Dye-Free

    Not Tested on Animals

    Formula Made in the USA

    Soothe aching muscles and joints with NatureWell™ Clinical 

    In an easy to use roll-on applicator, this product glides on for targeted, cooling relief. Formulated with 5% Menthol and 3.25% Eucalyptus Oil to reduce aches and pain. This no-mess, fast acting gel temporarily alleviates any aches or pains. Great for muscle strains, sprains and cramps.

    BENEFITS

    • FAST RELIEF 
    • SOOTHES ACHES AND PAINS
    • QUICK VANISHING ODUR
    • NO MESS APPLICATOR

    KEY INGREDIENTS

    • 5% Menthol - Helps relieve joint and muscle pain
    • 3.25% Eucalyptus Oil - Helps relieve sore, stiff muscles
    • Kava Extract - Helps provide additional cooling benefits
    • Arnica & Calendula Extracts - Helps calm and comfort

    DISTRIBUTED BY:

    NATUREWELL™

    PHOENIX, AZ 85016

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MUSCLE AND JOINT PAIN RELIEF GEL 
    menthol, eucalyptus globulus leaf oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61383-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL3.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PIPER METHYSTICUM ROOT (UNII: BOW48C81XP)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61383-701-012 in 1 BLISTER PACK11/16/2016
    1NDC:61383-701-9696 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 finalpart34811/16/2016
    Labeler - Dimensional Merchandising Inc. (076693183)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc.076693183manufacture(61383-701)