FDA Label for Synoflex Patch
View Indications, Usage & Precautions
Synoflex Patch Product Label
The following document was submitted to the FDA by the labeler of this product Sola Pharmaceuticals. 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 Hcl 4%
Menthol 5%
Purpose
Topical Anesthetic
Uses
For the temporary relief of pain
Warnings
For external use only
Do Not Use
- More than 1 patch on your body at a time or on cut, irritated, or swollen skin
- On puncture wounds
- 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 label
- rare cases of serious burns have been reported with products of this type
- do not apply to wounds or damaged, broken, or irritated skin
- do not allow contact with the eyes and 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
- dispose of used patch in a 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.
Stop Use And Ask A Doctor If
- condition worsens
- 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 was applied
If Pregnant Or Breast-Feeding
ask a healthcare 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
Adults and children over 12 years: Clean and dry the affected area
- Open pouch and remove one patch
- Remove the protective film from the patch and apply patch to the affected area
- Reseal pouch containing unused patches after each use
- Use 1 patch for up to 12 hours
Children 12 years or younger: ask a doctor
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Other Ingredients
Acrylic Adhesive
Questrions Or Comments?
866-747-7365
Package Label.Principal Display Panel
​​Manufactured for:
Sola Pharmaceuticals LLC
Baton Rouge, LA 70810
SynoFlex Patch
Topical Pain Patch
For temporary relief of pain
NDC 70512-015-15
Qty: 15 Flex Patches
(5 per Resealable Pouch) x 3
* Please review the disclaimer below.
