FLANAX BACK PAIN RELIEF PATCH

Manufacturer
Belmora Llc
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:23:06

Label at a glance#

ProductFLANAX BACK PAIN RELIEF
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

 Temporarily relieves minor pain

Dosage and administration

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 bac...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

 Temporarily relieves minor pain

​Warnings

WARNINGS SECTION

 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 SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2
1737778lidocaine 4 % Medicated PatchSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27854-311-01FLANAX BACK PAIN RELIEF0.24 g in 1 PATCHPATCH0.242
27854-311-01FLANAX BACK PAIN RELIEF1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27854-311FLANAX BACK PAIN RELIEF (LIDOCAINE) PATCH [BELMORA LLC]2Current NDC, Legacy NDC, 2 package rows20241009_af4bf57c-f250-4506-83eb-e0f253e96062.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
27854-31127854-311-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLANAX BACK PAIN RELIEFLIDOCAINEBelmora Llcaf4bf57c-f250-4506-83eb-e0f253e960622024-10-04WarningsExact identifier
ndc (package): 27854-311-01
ndc (product): 27854-311
ndc11 (package): 27854031101
spl id: bf5fa82e-d462-484c-a240-d542430a91fc
spl set id: af4bf57c-f250-4506-83eb-e0f253e96062

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.