Joint And Muscle Pain
FDA Label NDC 55379-404

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biozone Laboratories, Inc. for the product Joint And Muscle Pain (NDC 55379-404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, directions, warnings, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Menthol (5%)

Otc - Purpose

Topical Analgesic

Directions

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

  • Backache
  • Arthritis
  • Bruises
  • Sprains
    • 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.

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.

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.

Package Label.Principal Display Panel

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Image Of Tube Label (Tube Shk10 1)

Image Of Tube Label (Tube Shk10 1)


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