FDA Label for Leader Ultra Strength Pain Relieving
View Indications, Usage & Precautions
Leader Ultra Strength Pain Relieving 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 ingredient Purpose
Menthol 5%..........................................................Topical Analgesic
Otc - Purpose
Uses
temporarily relieves mino 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
- 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.
If swallowed, get medical help or contact a Poison Control Center immediately.
Indications & Usage
Directions
- open pouch and remove patch
- if desired, cut patch to size
- peel off protective backing and apply sticky side to affected area
- 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:consult a doctor
Storage And Handling
Other information
- store at 20° to 25°C (68° to 77°F)
Inactive Ingredient
Inactive ingredients
butylated hydroxytoluene, carboxymethylcellulose sodium, castor oil, edetate disodium, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminum hydroxide, methylparaben, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide
Dosage & Administration
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Package Label.Principal Display Panel
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