Label: CAREALL MUSLE AND JOINT- menthol gel

  • NDC Code(s): 51824-014-03
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 1, 2021

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  • ACTIVE INGREDIENT

    Menthol 2.5%

  • PURPOSE

    Topical Analegesic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children.  If swallowed, get medical help of contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, and bruises

  • WARNINGS

    For External Use Only.

    Do not use:

    On wounds or damaged skin

    With a heating pad

    On children 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 eith eyes or mucous membranes

    Do not bandage tightly

    Stop use and ask a Doctor if:

    Condition worsens or symptoms persist for more than 7 days

    Symptoms clear up and occur again within a few days

    Excessive skin irritation occurs

  • DOSAGE & ADMINISTRATION

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

    Children under 12 years of age: ask a doctor

  • INACTIVE INGREDIENT

    Camphor, Carbomer 980, Isopropyl alcohol, Methylparaben, Polysorbate 60, Potassium Sorbate, Trolamine, Purified water

  • PRINCIPAL DISPLAY PANEL

    MJG3 Carton Artwork

  • INGREDIENTS AND APPEARANCE
    CAREALL MUSLE AND JOINT 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (Inbetween clear and white in color) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-014-0385 g in 1 TUBE; Type 0: Not a Combination Product06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2012
    Labeler - New World Imports, Inc (075372276)