FDA Label for Leader Ultra Strength Muscle Rub Topical Analgesic

View Indications, Usage & Precautions

Leader Ultra Strength Muscle Rub Topical Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. 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 - Purpose



Active ingredientsPurpose
Camphor 4%Topical Analgesic
Menthol 10.0%Topical Analgesic
Methyl Salicylate 30%Topical Analgesic

Uses



for the temporary relief of minor aches and muscles and joints associated with:

  • ♦arthritis
  • ♦simple backache
  • ♦strains
  • ♦sprains

Warnings



For external use only


Do Not Use



  • ♦with a heating pad
  • ♦on wounds, damaged, broken or irritated skin
  • ♦on a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor



Ask a doctor before use if you have redness over the affected area


When Using This Product



  • ♦use only as directed
  • ♦do not swallow
  • ♦do not bandage tightly
  • ♦avoid contact with the eyes and mucous membranes

Stop Use And Consult A Doctor If



  • ♦skin redness or irritation develops
  • ♦condition worsens or pain lasts for more than 7 days
  • ♦symptoms clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • ♦Adults and children 12 years of age and older: apply to affected area not more than 3 or 4 times daily
  • ♦children under 12 years of age: ask a doctor

Other Information



Store at room temperature 15° - 30° C (59° - 86° F)


Inactive Ingredients



Carbomer, Disodium EDTA, Glyceryl Stearate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Trolamine, Water.


Questions Or Comments?



1-866-567-8600


Other



DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017


Principal Display Panel - 113 G Tube Carton



NDC 70000-0208-1

ULTRA STRENGTH
Muscle Rub

Topical Analgesic Pain Relief Cream

Deep Penetrating Relief of Muscle and Arthritis Pain
Non-Greasy Cream

COMPARE TO
BENGAY®
ULTRA STRENGTH
active ingredients*

100% Money Back Guarantee

NET WT 4 OZ (113 g)


* Please review the disclaimer below.