Label: COLD AND HOT- menthol spray

  • 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 16 %

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  • Inactives

    Glycerin.

    Propylene Glycol

    SD Alchohol 40-2(55%)

    Water (283-016)

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  • Uses

    Temporarily relieves minor pain associated with:

    arthritissimple

    backachemuscle

    strainss

    prains

    bruise

    scramps

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  • Indication

    Temporarily relieves minor pain

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  • Directions

    Spray affected are with desired amount of product

    Product will dry quickly on its own and doest not to be rubbed in

    Repeat as necessary but not more than 3-4 times dilay

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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 spray on face

     Avoid inhaling spray mist and fumes

    Stop use and ask docotor if;

    Condition Worsesns

    Redness is presnt for more than 7 days

    Irritation developes

    Symptomps persist for mor than 7 dyas or clear up and occur again within a few days.


    Flamalble
    Do not use near heat or flame or while smoking.

    Avod long term  storage  above 104oF (400C)

    Do not puncture of or incinerate.Congents under pressure.

    Do not store at temreture above 120oF (490C)

    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 spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59240-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 16 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    METHYL SALICYLATE  
    THYMOL  
    ZINC STEARATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59240-002-10 150 mL in 1 CAN
    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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