Bio-Scriptives Extreme PR

Dosage form: lotion
Ingredients: Menthol 5.11g in 113g
Labeler: BioChemics, Inc.
NDC Code: 60608-015

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 Facts

Active Ingredient

Natural Menthol 4.4%

Purpose

Analgesic

UsesFor 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 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 IngredientsDeionized 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)


BIO-SCRIPTIVES EXTREME PR 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60608-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol5.11 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
OLIVE OIL 
PROPYLENE GLYCOL 
EUCALYPTUS OIL 
SODIUM ALGINATE 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
POLYOXYL 100 STEARATE 
SEAWEED 
ALTHAEA OFFICINALIS LEAF 
ALLANTOIN 
XANTHAN GUM 
Packaging
#Item CodePackage Description
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)

Revised: 07/2011
 
BioChemics, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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