FDA Label for Leader Cooling Pain Relief Topical Analgesic
View Indications, Usage & Precautions
Leader Cooling Pain Relief 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.
Other
Drug Facts
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
Active Ingredient
Menthol 4%
Purpose
Topical analgesic
Uses
for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, and sprains
Warnings
For external use only
Otc - Ask Doctor
Ask a doctor before use if you have sensitive skin
When Using This Product
⬥ Avoid contact with eyes⬥ Do not apply to wounds or damaged skin⬥ Do not use with other ointments, creams, sprays or liniments⬥ Do not apply to irritated skin or if excessive irritation develops⬥ Do not bandage tightly⬥ Wash hands after use with cool water⬥ Do not use with heating pads or heating devices
Otc - Stop Use
Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.
Flammable
⬥ keep away from fire or flame
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately.
Directions
⬥ Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily⬥ Children under 2 years of age: consult a doctor.
Other Information
Store in a cool dry place with lid closed tightly.
Inactive Ingredients
aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.
Questions Or Comments?
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Principal Display Panel - 89 Ml Tube Label
LEADER™
NDC 70000-0618-1
Cooling
Pain Relief
Gel
Menthol, 4% | Topical Analgesic
Pain Relieving Gel
For Backache
Muscle Pain
Joint Pain
Soothing
Menthol
COMPARE TO
BIOFREEZE®
active ingredient*
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3 FL OZ (89 mL)
* Please review the disclaimer below.