JOINT AND MUSCLE PAIN - menthol cream 
BioZone Laboratories, Inc.

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.

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Drug Facts

Menthol (5%)

Topical Analgesic

Directions

Provides penetrating temporary relief for minor pain in muscles and joints associated with:

Warnings

Directions

Inactive Ingredients

Water, Butylene Glycol, Prunus amygdalus dulcis (Sweet Almond) Oil, PEG-12 Glyceryl Distearate, Cetyl Alcohol, Glyceryl Stearate, Cyclomethicone, PEG-100 Stearate, Dimethicone, Aloe barbadensis Leaf Extract, Ehtylhexylglycerin, Carbomer, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Triethanolamine, Xanthan Gum.

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image of tube label


JOINT AND MUSCLE PAIN 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55379-404
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol50 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55379-404-8585 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/15/2009
Labeler - BioZone Laboratories, Inc. (555564293)

Revised: 7/2010
Document Id: ac502553-75ab-458f-8130-9b6013c2004c
Set id: 8d0cb441-4cc9-4225-abd5-e034a6b834b8
Version: 6
Effective Time: 20100728
 
BioZone Laboratories, Inc.