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  5. Label Information: Arthritis Leader

FDA Label for Arthritis Leader

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. DOSAGE & ADMINISTRATION
    5. INACTIVE INGREDIENT
    6. OTC - PURPOSE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arthritis Leader Product Label

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



Trolamine Salicylate 10.0%


Indications & Usage



Uses

Temporarily relieves minor pain associated with:  arthritis, simple backache, muscle strains, sprains, bruises, and cramps.


Warnings



Warnings

For external use only. 

Allergy alert: if prone to allergic reaction from aspirin or salicylate, contact a doctor before use

When using this product: use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucous membranes, and do no apply to wounds or damaged skin

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, redness present, or irritation develops

If pregnant or breast-feeding, ask a health care professional before use


Dosage & Administration



Directions

Adults and children over 12 years of age:  apply generously to affected area, massage into painful area until thoroughly absorbed into skin, repeat as necessary, but not more than 4 times daily.  Children 12 years or younger:  ask a doctor.


Inactive Ingredient



Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.


Otc - Purpose



Purpose

Pain relieving gel.



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.


Package Label.Principal Display Panel



Leader Arthritis Cream with Aloe.

Carton image - carton

Carton image - carton



* Please review the disclaimer below.