FLANAX BACK PAIN RELIEF- lidocaine patch 
Belmora Llc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FLANAX BACK PAIN RELIEF PATCH

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

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• 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

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

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FLANAX BACK PAIN RELIEF 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-311
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27854-311-011 in 1 POUCH02/01/2020
10.24 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2020
Labeler - Belmora Llc (112753244)

Revised: 1/2020
Document Id: 08984a42-e04e-467f-b19e-dfc61cb4d730
Set id: af4bf57c-f250-4506-83eb-e0f253e96062
Version: 1
Effective Time: 20200106
 
Belmora Llc