Panitrol
FDA Label NDC 59940-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Enzyme Labs for the product Panitrol (NDC 59940-001). 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, indications & usage, inactive ingredient, warnings, otc - do not use, otc - ask doctor, otc - when using, 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

Indications & Usage

For the temporary relief of minor aches and pains associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Inactive Ingredient

Aloe, Avocado Oil, Ceteareth-20, Cyclomethicone, Grape Seed Oil, MedFlex Relief Proprietary Herbal Blend, Methyl Glucose Sesquistearate, Natural Oil of Wintergreen, Phenoxyethanol, Methylparaben, Shea Butter, Steareth-2, Steareth-10, Stearic Acid, Water

Warnings

For external use only.

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad

Otc - Ask Doctor

Ask a doctor before use if you are

  • prone to allergic reactions to salicylates, including aspirin
  • using product on a child under 12 years of age

Otc - When Using

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive skin irritation occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed get medical help or contact a poison center right away.

Dosage & Administration

Directions

  • adults and children 12 years of age and older:  apply to affected area no more than 3 to 4 times daily
  • children under 12 years of age: consult a physician
  • apply generously and massage into affected areas until completely absorbed
  • apply before and after sports or exercise to help soothe aching muscles, muscle strain
  • repeat as needed up to four times per day

Storage And Handling

store in a cool, dry place away from direct sunlight

Package Label.Principal Display Panel

Penetrating Pain Relief

Temporary Relief of Minor Aches and Pains Associated with Arthritis, Simple Backache, Sprains, Bruises and Strains.


  • soothing and medicated analgesic rub for aching joints and muscles
  • effective for pre-exercise warm-up
  • penetrating pain relief
  • with skin moisturizing conditioners aloe, shea butter, avocado, and grape seed oil
  • contains Enzyme Labs clinically tested Panitrol herbal formula

    • Panitrol Label (Panitrollabel)

    Panitrol Label (Panitrollabel)



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