Label: BIO-SCRIPTIVES EXTREME PR- menthol lotion

  • 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 July 22, 2011

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  • Active Ingredient

    Natural Menthol 4.4%

  • Purpose

    Analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with arthritis, sprains, strains, and back pain.
  • Warnings

    ■  Avoid Contact with eyes.
    ■  Do not use on wounds or damaged skin.

    For external use only.

  • Stop use and ask doctor if

    ■  condition worsens/lasts more than 7 days.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • Directions

    ■  Do not use if safety seal is broken.
    ■  Shake well before each application.
    ■  Apply and massage Extreme PR™ onto treatment area up to 4 times daily.


  • Inactive Ingredients

    Deionized Water, Isopropanol, Olive Oil, Propylene Glycol, Eucalyptus Oil, Sodium Alginate, Cetyl Alcohol, Glyceryl Stearate and PEG-100 Stearate, Kelp Extract, Marshmallow Extract, Allantoin, and Xanthan Gum.
  • Questions:

    Distributed by BioChemics

    dba Bio-Scriptives (978) 750-0790

    99 Rosewood Drive, #260

    Danvers, MA 01923


  • LABEL IMAGES (FRONT AND BACK)



    Extreme PR Front
    Extreme PR Back
  • INGREDIENTS AND APPEARANCE
    BIO-SCRIPTIVES EXTREME PR 
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60608-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5.11 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    SEAWEED (UNII: 477TV3P5UX)  
    ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60608-015-00113 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/15/2011
    Labeler - BioChemics, Inc. (802946426)
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