Label: COLD AND HOT- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 07/13

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

  • Acitves

    Menthol 7.5%

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  • Inactives

    aloe barbadensis leaf juice, beeswax, benzyl alcohol, capsaicin, cetearyl alcohol, cetyl alcohol, cetyl esters, cetyl palmitate, citrus paradise (grapefruit) peel oil, di-PEG-2 soyamine IPDI, disodium LPDL, distearyldimonium chloride, eucalyptus globules leaf oil, glycerin, hydrogenated olive oil, jojoba esters, melaleuca alternifolia (tea tree) leaf oil, menthe viridis (spearmint) leaf oil, olea europaea (olive) fruit oil, olea europaea (olive) oil unsaponifiables, polysorbate 60, potassium hydroxide, propanediol, sorbitan olivate, sorbitan palmitate, steareth-2, steareth-21, stearyl alcohol, water

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  • Uses

    Temporarily relieves minor pain associated with:

    arthritis

    backache  

    bodyaches

    muscle pains

    leg cramps

    bursitis

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  • Indication

    Temporarily relieves minor pain

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  • Directions

    Adults and children over 1 years:apply generously to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary, but no more than  4 times daily.

    Children 12 years or younger: ask a doctor.

    Close cap tighlty after use.

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  • Warnings

    For External use only

    When using this product

     Use only as directed

     Do not bandage tightly or with heating pad

     Avoid contact with eyes and mucous membranes

     Do not apply to wounds or damagged, broken or irritated skin

     Do not expose the area treated with product to heat or direct sunlight.

    Stop use and ask docotor if;


    Condition Worsesns, Symptomps persist for mor than 7 days or clear up and occur again within a few days, Irritation developes.

    If pregnant or breast feeding

     Ask health professionals before use.

    If sollowed get medical help or contact poison control center right away.

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  • Keep Out of Reach of Childrens

    Keep out of reach of childrens.

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  • Productt Label

    Product Label

    image Product Label

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  • INGREDIENTS AND APPEARANCE
    COLD AND HOT 
    menthol cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59240-003
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 0.075 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    YELLOW WAX  
    BENZYL ALCOHOL  
    CAPSAICIN  
    CETOSTEARYL ALCOHOL  
    CETYL ALCOHOL  
    CETYL ESTERS WAX  
    CETYL PALMITATE  
    CITRUS PARADISI FRUIT OIL  
    EDETATE DISODIUM  
    DISTEARYLDIMONIUM CHLORIDE  
    EUCALYPTUS OIL  
    GLYCERIN  
    OLIVE OIL  
    HYDROLYZED JOJOBA ESTERS (ACID FORM)  
    SPEARMINT  
    POLYSORBATE 60  
    POTASSIUM HYDROXIDE  
    PROPANEDIOL  
    SORBITAN OLIVATE  
    PEG-80 SORBITAN PALMITATE  
    STEARETH-2  
    STEARETH-21  
    STEARYL ALCOHOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59240-003-01 25 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 07/18/2013
    Labeler - MAGVERZ INC (078712269)
    Registrant - MAGVERZ INC (078712269)
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