FDA Label for Point Relief Lidospot
View Indications, Usage & Precautions
Point Relief Lidospot Product Label
The following document was submitted to the FDA by the labeler of this product Fabrication Enterprises. 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 4.0% w/w ...... Purpose: Topical anesthetic
Menthol 1.0% 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 allow contact with the eyes
- Do not use at the same time as other 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 still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Do Not Use
- More than one 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
- If you are allergic to any active or inactive ingredients
- If pouch is damaged or opened.
Stop Use And Consult A Doctor If
- Condition worsen
- Redness is present
- Irritation develops
- Symptoms persist for more than 7 days or clear up and occur again within a few days
- You experience signs of skin injury such as pain, swelling or blistering where the product applied.
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out Of Reach Of Children And Pets
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 stickly 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
Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaolin, Titanium Dioxide, Polysorbate 80, Mineral Oil, Propylene Glycol, L(+)-Tartaric Acid, Polyacrylic Acid, PolyvinylPyrrolidone K90, Hydroxyacetophenone, Water
Other Information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Package Label. Principal Display Panel
* Please review the disclaimer below.