Label: PANITROL XR- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated January 1, 2011

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  • ACTIVE INGREDIENT

    Menthol 5%

  • 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.

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
  • 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
  • WHEN USING

    When using this product

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

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

  • 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

  • QUESTIONS

    Call 1-877-500-5529

    Monday through Friday, 9am-5pm or customerservice@enzymelabs.com

  • 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


  • INGREDIENTS AND APPEARANCE
    PANITROL  XR
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59940-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.25 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-10 (UNII: FD0913P475)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59940-001-0385 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2010
    Labeler - Enzyme Labs (617686980)
    Registrant - Enzyme Labs (617686980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupack Midwest Inc.139637433manufacture
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