Label: LEADER ULTRA STRENGTH PAIN RELIEVING- menthol patch

  • 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 December 28, 2017

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  • ACTIVE INGREDIENT

    Active ingredient                                                     Purpose

    Menthol 5%..........................................................Topical Analgesic

  • PURPOSE

    Uses 

    temporarily relieves mino aches and pains of muscles and joints associated with:

    • simple backache 
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions
  • ASK DOCTOR

    Ask a doctor before use if you have

    • redness over the affected area
  • WHEN USING

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Directions

    • open pouch and remove patch
    • if desired, cut patch to size
    • peel off protective backing and apply sticky side to affected area
    • adults and children 12 years of age and older:apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age:consult a doctor
  • STORAGE AND HANDLING

    Other information

    • store at 20° to 25°C (68° to 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    butylated hydroxytoluene, carboxymethylcellulose sodium, castor oil, edetate disodium, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminum hydroxide, methylparaben, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY

    CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com

    1-800-200-6313

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LEADER ULTRA STRENGTH PAIN RELIEVING 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0185-11 in 1 BOX11/28/2016
    15 in 1 POUCH
    11 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/28/2016
    Labeler - Cardinal Health, Inc. (097537435)
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