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

dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate,
tartaric acid, titanium dioxide, tween 80, water

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

FLANAX BACK PAIN RELIEF 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-311
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-311-01	1 in 1 POUCH	02/01/2020
1		0.24 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2020

Labeler - Belmora Llc (112753244)