FDA Label for Leader Extra Strength Medicated Pain Relief Patch
View Indications, Usage & Precautions
Leader Extra Strength Medicated Pain Relief Patch 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
Active ingredient Purpose
Menthol 5%.............................................. Topical analgesic
Otc - Purpose
Uses
Temporarily relieves minor pain associated with:
- arthritis
- simple backache
- bursitis
- tendonitis
- muscle strains
- muscle sprains
- bruises
- cramps
Warnings
Warnings
For external use only
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - When Using
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged skin
Otc - Stop Use
Stop use and ask a doctor if:
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- skin irritation develops
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.
Indications & Usage
Directions
- adults and children 12 years old
- peel off protective backing and apply sticky side to affected area
- should be used up to 8 hours
- should be used no more than 3 times a day
- children under 12 years of age consult a doctor
Storage And Handling
Other information
- store at room temperature, not to exceed 85°F (30°C)
Inactive Ingredient
Inactive ingredients
1,3-butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disdoium edate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, metacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium oxide, tocopherol acetate
Dosage & Administration
DISTRIBUTED BY:
CARDINAL HEALTH
DUBLIN, OHIO 43017 USA
Package Label.Principal Display Panel
* Please review the disclaimer below.