FDA Label for Flanax Back Pain Relief
View Indications, Usage & Precautions
Flanax Back Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Belmora Llc. 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.
Drug Facts
Active Ingredients
Lidocaine 4%
Purpose
Topical Anesthetic
Uses
Temporarily relieves minor pain
Warnings
For external use only
Do not use if pouch is damaged or opened.
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 pouch
• 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 manner that always keeps product away from children and pets. Used patches still contain the drug products 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 health professional before use.
Otc - Keep Out Of Reach Of Children
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 affected area • Carefully remove backing film from patch • Apply one patch to affected area • Do not use more than 2 patches in 24 hours unless directed by a doctor.
Children under 12 years: Ask a doctor.
How to apply
• Remove backing from patch by firmly grasping both ends and gently pull backing to separate it in the middle.
• Carefully remove one portion of backing from patch and apply exposed portion of patch to affected area.
• Once exposed portion of patch is positioned, remove remaining backing to completely apply patch to affected area.
Inactive Ingredients
dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate,
tartaric acid, titanium dioxide, tween 80, water
Other
LONGER LASTING PAIN RELIEF
LIDOCAINE PATCH
√ For back, neck, leg & arm pain relieving ointment on a breathable adhesive pad
1 Patch | 3-15/16” x 5-1/2” (10 cm x 14 cm)
Questions/Comments?
www.flanax.com
Call 1 888 779 2877 9AM-5PM EST
Distributed by: Belmora LLC
2011 Crystal Dr. Suite 400, Arlington, VA 22202
Packaging
* Please review the disclaimer below.