FDA Label for Lidocaine Pain Relief Patch
View Indications, Usage & Precautions
Lidocaine Pain Relief Patch Product Label
The following document was submitted to the FDA by the labeler of this product Foshan Aqua Gel Biotech Co.,ltd.. 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 Ingredients
Lidocaine 4%
Menthol 1%
Purpose:
Topical anesthetic
Topical anesthetic
Uses:
For the temporary relief of pain.
Warnings
For external use only
Avoid contact with eyes.
Do Not Use
- if you are allergic to any active and inactive ingredients listed in this patch
- if pouch is damaged or opened
- on raw surfaces or blistered areas, open wounds, or on damaged, cut, irriated or sensitive skin
- for more than one week without consulting a doctor.
When Using This Product
- use only as directed. Read and follow all directions and warnings on this package
- do not allow contact with eyes or mucous membranes
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- do not use at the same time as other topical analgesics
- do not reuse patch
- dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Stop Use And Ask A Doctor If
- conditions worsens
- rash, itching or skin irritation develops
- symptoms persist for more than 7 days or clear up and occurs again within a few days
- you experience signs 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
Adults and children over 12 years of age:
- clean and dry affected area
- strip off the clear protective film and place adhesive patch over affected area
- leave in place for up to 8 hours
- wash hands thoroughly after applying or removing patch.
Children under 12 years: ask a doctor before use.
Other Information
Store below 25°C (77°F). Avoid direct sunilght.
Inactive Ingredients:
dihydroxyaluminum aminoacetate, glycerin,kaolin,methylparaben,polyacrylic acid,polysorbate 80,propylene glycol,propylparaben, povidone,sodium polyacrylate, tartaric acid,tatanium dioxide,water.
Questions Or Comments?
Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)
Dosage And Administration
Lidocaine Pain Relief Patch contains 4% Lidocaine and 1% Menthol.
* Please review the disclaimer below.