PediFix Lidocaine Pain-Relief Patches

Manufacturer
PediFix, Inc | PediFix | AKRON
Effective date
2025-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:26

Label at a glance#

ProductPediFix Lidocaine Pain-Relief Patches
Active ingredientLIDOCAINE
Label structure15 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

lIDOCAINE 4%

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

• On cut, irritated, or swollen skin. • On puncture wounds. • For more than one week without
consulting a doctor. • If you are allergic to any active or inactive ingredient. • If the pouch is
damaged or opened.

OTC - WHEN USING SECTION

  • Use only as directed.
  • Read and follow all directions and warnings on this carton.
  • Avoid contact with the eyes, mucous membranes, or rashes.
  • Do not use at the same time as other topical analgesics.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Do not microwave.
  • Dispose of used patches in a manner that always keeps the product away from children and pets. Used patches still contain the drug and could produce serious adverse effects if a child or pet chews or ingests them.

OTC - STOP USE SECTION

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, or blistering.
  • Conditions worsen.
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222) immediately.

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • Clean and dry the affected area.
  • Carefully remove the backing from the patch starting at the corner.
  • Apply the sticky side of the patch to the affected area.
  • Use one patch for up to 8 hours.
  • Discard the patch after a single use.

Children under 12 years of age: Consult a physician before use.

OTHER SAFETY INFORMATION

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

INACTIVE INGREDIENT SECTION

Acrylic block co-polymer adhesive

SPL UNCLASSIFIED SECTION

Call 1-800-PEDIFIX (733-4349),
write to PediFix, 301 Fields Lane,
Brewster, NY 10509, or
visit pedifix.com.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PediFix

Meidcal Footcare

Lidocain

Pain-Relief

Patches

Relieve Pain Instantly!

Scissor-Trim to Any Size

Water-Resistant

Unscented

4% Lidocaine Topical Anesthetic

Maximum Strength

6

Medicated Patches

Trim to Any Size

PediFixLidocainePatchesPediFixLidocainePatches

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

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
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
68927-3700-1PediFix Lidocaine Pain-Relief Patches3 in 1 CELLO PACKPATCH31
68927-3700-1PediFix Lidocaine Pain-Relief Patches2 in 1 CONTAINERPATCH21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68927-3700PEDIFIX LIDOCAINE PAIN-RELIEF PATCHES (LIDOCAINE PAIN-RELIEF PATCHES) PATCH [PEDIFIX, INC]1Current NDC, 2 package rows20250507_346550b9-d2ba-184e-e063-6394a90a591a.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68927-370068927-3700-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
POLYQUATERNIUM-70L414VCS5YIACT

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
PediFix Lidocaine Pain-Relief PatchesLIDOCAINE PAIN-RELIEF PATCHESPediFix, Inc346550b9-d2ba-184e-e063-6394a90a591a2025-05-05WarningsExact identifier
ndc (package): 68927-3700-1
ndc (product): 68927-3700
ndc11 (package): 68927370001
spl id: 346550b9-d2bb-184e-e063-6394a90a591a
spl set id: 346550b9-d2ba-184e-e063-6394a90a591a

Reported adverse events (FAERS/openFDA)#

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