FLANAX BACK PAIN RELIEF- lidocaine patch

Flanax Back Pain Relief by

Drug Labeling and Warnings

Flanax Back Pain Relief by is a Otc medication manufactured, distributed, or labeled by Belmora LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water

SPL UNCLASSIFIED SECTION

LONGER LASTING PAIN RELIEF

For back, neck, leg & arm pain relieving ointment on a breathable adhesive pad

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

INGREDIENTS AND APPEARANCE

FLANAX BACK PAIN RELIEF 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
KAOLIN (UNII: 24H4NWX5CO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POVIDONE K90 (UNII: RDH86HJV5Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-333-01	1 in 1 POUCH; Type 0: Not a Combination Product	12/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/15/2021

Labeler - Belmora LLC (112753244)