​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 00:23:03

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 o...

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

DirectionsDirections
• 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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27854-333-01Flanax Back Pain Relief1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27854-333FLANAX BACK PAIN RELIEF (LIDOCAINE) PATCH [BELMORA LLC]2Current NDC, Legacy NDC, 1 package rows20241009_46d33346-e582-4af1-b81a-feca7033dceb.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
27854-33327854-333-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12021-12-09full-release2026-05-31 23:46:03

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 LLC46d33346-e582-4af1-b81a-feca7033dceb2024-10-04WarningsExact identifier
ndc (package): 27854-333-01
ndc (product): 27854-333
ndc11 (package): 27854033301
spl id: 11c5c124-3698-4ff3-b514-203c35325ca3
spl set id: 46d33346-e582-4af1-b81a-feca7033dceb

Reported adverse events (FAERS/openFDA)#

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