FDA Label for Leader Ultra Strength Muscle Rub

View Indications, Usage & Precautions

Leader Ultra Strength Muscle Rub 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.

Otc - Active Ingredient



Active ingredients                                 Purpose

Camphor 4%...................................Topical analgesic

Menthol 10%...................................Topical analgesic

Methyl salicylate 30%.......................Topical analgesic


Otc - Purpose



Uses temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



Warnings

For external use only


Otc - 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

Otc - Ask Doctor



Ask a doctor before use if you

  • have a redness over the affected area

Otc - When Using



When using this product

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

Otc - 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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Indications & Usage



Directions

  • use only as directed
  • 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: ask a doctor

Storage And Handling



Other information

  • store between 20° to 25°C (68° to 77°F)
  • lot no. & exp. date: see carton or see crimp of tube

Inactive Ingredient



Inactive ingredients

glycerin, isopropyl myristate, lanolin, methylparaben, petrolatum, polysorbate 60, potassium cetyl phosphate, propylparaben, sorbitan monostearate, stearyl alcohol, water


Dosage & Administration



DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to care™since 1979

Made in Korea


Package Label.Principal Display Panel




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