FDA Label for Lidospot Patch
View Indications, Usage & Precautions
Lidospot Patch Product Label
The following document was submitted to the FDA by the labeler of this product Fabrication Enterprises 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.
Active Ingredient
Lidocaine 4% w/w ...... Purpose: Topical anesthetic
Menthol 1% w/w ...... Purpose: Topical analgesic
Purposes
Topical anesthetic (Lidocaine)
Topical analgesic (Menthol)
Uses
Temporarily relieves minor pain.
Warnings
For external use only
When Using This Product:
- Use only as directed
- Read and follow all directions and warnings on this carton
- Do not alow contact with the eyes
- Do not use at the same time as other topical analgesics
- Do not bandage tightly or apply local heat (such as heating pads) to the area of use
- Do not microwave
- Dispose of used patch in manner that always keeps product away from children and pets. Used patches stil containthe drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Do Not Use:
- More than 1 patch on your body at a time
- On cut, irritated or swollen skin
- On puncture wounds
- For more than one week without consulting a doctor
- lf you are allergic to any active or inactive ingredients
- lf pouch is damaged or opened.
Stop Use And Ask A Doctor If:
Condition worsens
Redness is present
lrritation develops
Symptoms persist for more than 7 days or clear up and occur again within a few days
You experiencesigns of skin injury such as pain, swelling or blistering where the product was applied.
If Pregnant Or Breast-Feeding,
Ask a health professional before use
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Adult and Children 12 years of age and over:
- Clean and dry affected area Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours.
Children under 12 years of age:consult a physician.
Inactive Ingredients
Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin,L(+)-Tartaric Acid,Mineral oil,Polysorbate 80, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide,Water,
Questions Or Comments
1-800-431-2830
Other Information
- Store in a clean, dry place outside of direct sunlight, Protect from excessive moisture.
Package Label. Principal Display Panel
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