FDA.reportPublic FDA data

pain relief patch

Manufacturer
Bionpharma Inc. | Sparsha Pharma USA, Inc.
Effective date
2024-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:22:25

Label at a glance#

Productpain relief patch
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

For the temporary relief of minor pain.

Dosage and administration

■ Adults and children 12 years of age and over: Clean and dry affected area ■ Apply immediately upon removal from pouch ■ Peel off the first liner and apply exposed patch to affected area ■ Peel off second liner while applying the rest of patch ■ Remove patch after 24 hours ■ Discard patch after single use. ■ Children under 12 years of age: Consult a doctor.

Storage and handling

Store in a clean, dry place away from direct sunlight. Store in original unopened pouch protected from moisture.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor pain.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

■ If you are allergic to any active or inactive ingredients of this product ■ On wounds or damaged, irritated or sensitive skin
■ More than one patch on your body at a time or with other topical analgesics at the same time
■ For more than one week without consulting a doctor ■ With a heating pad ■ If pouch is damaged or opened.

When using this product

OTC - WHEN USING SECTION

■ Avoid contact with the eyes ■ Use only as directed ■ Read and follow all directions and warnings on this
package ■ Do not bandage tightly or apply local heat to the area of use ■ Do not reuse patch ■ Keep this product away from pets and
children. Used patches still contain the drug product that can produce serious adverse effect if a child or pet chews or ingests this
patch

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ Condition worsens ■ Symptoms persist for more than seven days or clear up and occur again within a
few days ■ Localized skin reactions such as rash, pain, itching, redness, irritation, swelling or blistering occur where the product was
applied.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If chewed or swallowed, get medical help or contact a Poison Control Center right away (800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 12 years of age and over: Clean and dry affected area ■ Apply immediately upon removal from pouch ■ Peel off
the first liner and apply exposed patch to affected area ■ Peel off second liner while applying the rest of patch ■ Remove patch after
24 hours ■ Discard patch after single use.
■ Children under 12 years of age: Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store in a clean, dry place away from direct sunlight. Store in original unopened pouch protected from moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alicyclic hydrocarbon resin, mineral oil, polyester film, silicone-coated polyester film, styrene isoprene, styrene block copolymer.

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

Read directions and warning before use

KEEP OUT OF REACH OF CHILDREN AND PETS

Made in USA from Domestic and Imported Components

Distributed by:
Bionpharma Inc.
Princeton, NJ
08540

L0000735
R0623

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69452-409-04

maximum strength

a+ health TM

pain relief
lidocaine 4% patch
topical analgesic

• desensitizes aggravated nerves
• odor free, thin & flexible
• no-mess, single use application

24 hours

6 Patches

2.91" x 2.17"

cartoncarton

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
69452-409-04pain relief patch6 in 1 CARTONPATCH61
69452-409-04pain relief patch1 g in 1 POUCHPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-409PAIN RELIEF PATCH (LIDOCAINE 4%) PATCH [BIONPHARMA INC.]1Current NDC, 2 package rows20241004_19c69983-4e78-8ec5-e063-6394a90a84be.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-40969452-409-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGENATED C6-20 POLYOLEFIN (100 CST)39EYQ1W9RBIACT
LIDOCAINE98PI200987ACTIB
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85)1SSZ6HXE7PIACT
MINERAL OILT5L8T28FGPIACT

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
pain relief patchLIDOCAINE 4%Bionpharma Inc.19c69983-4e78-8ec5-e063-6394a90a84be2024-10-03WarningsExact identifier
ndc (package): 69452-409-04
ndc (product): 69452-409
ndc11 (package): 69452040904
spl id: 19c6a4d7-82a3-67b9-e063-6294a90a7794
spl set id: 19c69983-4e78-8ec5-e063-6394a90a84be

Reported adverse events (FAERS/openFDA)#

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