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  5. Label Information: Panitrol XR

FDA Label for Panitrol XR

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. INACTIVE INGREDIENT
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DOSAGE & ADMINISTRATION
    13. STORAGE AND HANDLING
    14. OTC - QUESTIONS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Panitrol XR Product Label

The following document was submitted to the FDA by the labeler of this product Enzyme Labs. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Otc - Questions



Call 1-877-500-5529

Monday through Friday, 9am-5pm or [email protected]


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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