FDA Label for Leader Medicated Relief Patch

View Indications, Usage & Precautions

Leader Medicated Relief Patch Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, Inc. 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.

Active Ingredient



Active IngredientPurpose
 DL-Camphor 1.2% Topical Analgesic
 L-Menthol 5.7% Topical Analgesic
 Methyl Salicylate 6.3% Topical Analgesic


Inactive Ingredient



Glyceryl Hydrogenated Rosinate, Styrene/Isoprene Copolymer, Hydrated Silica, Mineral Oil, Polyisobutylene (1300 MW), PEG-400, Zinc Oxide, Ys Resin.


Keep Out Of Reach Of Children



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


Indications & Usage



Temporary relief of aches and pains associated with arthritis, simple backache, strains, sprains, bruises.


Warnings



For External Use Only


Dosage & Administration



Adults and children over 12 years: clean and dry affected area. Carefully remove backing from patch. Apply sticky side of patch to affected area.

Wear one patch up to 8 hours. Repeat as necessary, no more than 4 times daily, no more than 7 consecutive days.

Children 12 years or younger, consult a physician.


Purpose



Topical Analgesic


When Using This Product:



  • Use only as directed
  • Avoid contact with eyes, mucous membranes or skin rashes.

Do Not Use



  • On wounds or damaged skin
  • If you are allergic to aspirin or salicylates or with other external analgesic products
  • With a heating pad
  • If you are allergic to any ingredients in this product.   

Top Use And Consult A Doctor



  • If rash, itching or excessive skin irritation develops
  • If condition worsens
  • If symptoms last more than 7 days or clear up and occur again.

Storage And Care



Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.


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