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Leader Ultra Strength Pain Relieving

Medically reviewed on December 28, 2017

Dosage form: patch
Ingredients: MENTHOL 50mg
Labeler: Cardinal Health, Inc.
NDC Code: 70000-0185

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.

Active ingredient                                                     Purpose

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

Uses 

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

  • simple backache 
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only.

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 a doctor before use if you have

  • redness over the affected area

When using this product

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

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.

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

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

Other information

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

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

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

LEADER ULTRA STRENGTH PAIN RELIEVING 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0185
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL50 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CARBOXYMETHYLCELLULOSE SODIUM 
CASTOR OIL 
EDETATE DISODIUM 
GELATIN 
GLYCERIN 
ISOPROPYL MYRISTATE 
KAOLIN 
ALUMINUM HYDROXIDE 
METHYLPARABEN 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
POLYVINYL ALCOHOL, UNSPECIFIED 
WATER 
SODIUM POLYACRYLATE (8000 MW) 
SORBITAN MONOOLEATE 
TARTARIC ACID 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:70000-0185-11 POUCH in 1 BOX
15 PATCH in 1 POUCH
11 PATCH in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/28/2016
Labeler - Cardinal Health, Inc. (097537435)

 
Cardinal Health, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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