FDA Label for Leader Maximum Strength Pain Relieving Analgesic
View Indications, Usage & Precautions
Leader Maximum Strength Pain Relieving 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.
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Drug Facts
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
Active Ingredients
Trolamine Salicylate
Purpose
Topical Analgesic
Uses
temporarily relieves minor pain associated with:
♦ arthritis♦ simple backache♦ muscle strains♦ sprains♦ bruises♦ cramps
Warnings
For external use only
Allergy Alert!
If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
When Using This Product
♦ use only as directed. Read an follow all directions and warnings on this label♦ do not bandage tightly or apply local heat (such as heating pads) to the area of use♦ avoid contact with eyes and mucous membranes♦ do not apply to wounds or damaged, broken or irritated skin♦ do not use at the same time as other topical analgesics
Otc - Stop Use
Stop use and consult a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
♦ redness is present♦ irritation develops
Otc - Pregnancy Or Breast Feeding
If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.
Directions
♦ Adults and children 12 years of age and older: apply to affected area not more than 4 times per day. Massage into painful area until thoroughly absorbed into skin♦ children under 12 years of age: do not use, consult a doctor
Other Information
Store at room temperature
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Sodium Hydroxide, Stearic Acid, Water.
Questions Or Comments?
1-866-567-8600
Principal Display Panel - 85 G Tube Carton
MAXIMUM STRENGTH
NDC 70000-0169-1
Pain Relieving Cream
Trolamine Salicylate, 10%
Topical Analgesic Rub
Temporary Relief of Minor Muscle Aches and Pains
Associated with Arthritis, Simple Backache or Sprains
Fast Acting • Odor Free • With Aloe
COMPARE TO
ASPERCREME®
MAXIMUM STRENGTH
active ingredients*
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NET WT 3 OZ (85 g)
* Please review the disclaimer below.