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Joint and Muscle Pain by BioZone Laboratories, Inc.

Dosage form: cream
Ingredients: Menthol 50mg in 1g
Labeler: BioZone Laboratories, Inc.
NDC Code: 55379-404

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

Menthol (5%)

Topical Analgesic

Directions

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

  • Backache
  • Arthritis
  • Bruises
  • Sprains

Warnings
  • For external use only. Do not use with a heating pad.  Do not apply to wounds or damaged skin. Do not bandage tightly after use.
  • Avoid contact with eyes.
  • Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days, or clear up and occur again within a few days.
  • Keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Directions
  • Adults and children over the age of 2: Apply generously to affected area.  Massage well into painful area. Repeat as necessary, but not more than 3 to 4 times daily.
  • Children under the age of 2: Do not use; consult a physician.

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.

Image: tube_shk10_1.jpg


JOINT AND MUSCLE PAIN 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55379-404
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol50 mg  in 1 g
Packaging
#Item CodePackage Description
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: 07/2010
 
BioZone Laboratories, Inc.

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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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