Label: MIRACLE RUB - menthol, methyl salicylate cream

  • 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 April 5, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient : Menthol  , Methyl Salicylate


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  • PURPOSE

    Purpose :  External Analgesic

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  • WARNINGS

    Warnings : For external use only

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  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children :  In case of accidental ingestion , get medical help or contact a Position Control center right away.

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  • DOSAGE & ADMINISTRATION


    Directions : adults and children 12 years and older ; apply to affected area no more than 3 to 4 times daily
                 
                     under 12 years: ask a doctor before use
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  • INACTIVE INGREDIENT

    Inactive Ingredients : aloe barbadensis leaf juice , water , stearic acid , cetyl alcohol , glyceryl stearate (and) PEG-100 stearate , petrolatum , dimethicone, triethanolamine , eucalyptus globulus leaf oil ,  imidazolidinyl urea,  methylparaben , propylparaben

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  • INDICATIONS & USAGE

    Uses : Temporarily relieves minor aches and pains of muscles and joints due to  * arthritis  * simple backache  * strains * sprains * bruises

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  • PRINCIPAL DISPLAY PANEL

     Image of Label

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  • INGREDIENTS AND APPEARANCE
    MIRACLE RUB 
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66391-0603
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.475 g  in 99 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 9.9 g  in 99 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66391-0603-0 99 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/01/2005
    Labeler - Winning Solutions (962718300)
    Registrant - Beautymanufacturing Solutions Corperation (783200723)
    Establishment
    Name Address ID/FEI Business Operations
    Beautymanufacturing Solutions Corperation 783200723 manufacture
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