NEOLINN Topical Pain Patch

Manufacturer
REMY Biosciences, Inc. | Blaine Labs Inc
Effective date
2021-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:44

Label at a glance#

ProductNEOLINN
Active ingredientLIDOCAINE, LEVOMENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Menthol 4%

Lidocaine 4%

OTC - PURPOSE SECTION

Purpose:

Menthol ....................Topical Analgesic

Lidocaine ..................Topical Anisthetic

INDICATIONS & USAGE SECTION

Uses:

Temporarily relieves minor aches and muscle pains associated with

arthritis, simple backache, strains, muscle soreness and stiffness.

WARNINGS SECTION

Warnings

   • For external use only.  Use only as directed by your healthcare

    professional.

OTC - DO NOT USE SECTION

   • Do not use: On open wounds, cuts, damaged or infevted skin, or in the

      eyes, mouth, genitals, or or any other mucus membrane.

   • Do not cover with tape or bandage.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

   • Keep out of reach of children.  Consult physician for children under 12.

   • Consult your physician if pregnant or pain persists or worsens.

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 12 years and over:  Apply patch to affected area 1

to 2 times daily or as directed.

Instructions for use:

   • Clean and dry the affected area

   • Open one single-use pouch

   • Remove patch and then remove clear film from patch surface

   • Apply patch directly to the affected area of pain

   • Wash hands with soap and water ater applyinfg patch

INACTIVE INGREDIENT SECTION

Other Ingredients:

Presure Sensitive Adhesive, Cannabidiol (Hemp Extract), Diethylene

Glycol Monoethyl Ether, Vitamin C [as Ascorbyl Palmitate]

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEOLINN

TOPICAL PAIN PATCH

Lidocaine 4%                        Qty: 30 Patches

Menthol 4%                Individually Packaged

                                                       Single Use

Lot#                                  NDC 81816-001-30

Exp. Date

Store in a dry, cool place.

For comments or questions, contact us at: support@neolinn.com

Manufactured for Neolinn, LLC by Remy Biosciences

17802  Sky Park Circle

Ste. 100

Irvine, CA 92614

Box

Neolinn Label BoxNeolinn Label Box

Pouch

Inner LabelInner Label

res

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
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81816-001-302023-01-30C16284748780-1f386c649-e4d3-0266-e053-dadaa90a7c1aNEOLINN Topical Pain Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81816-001-01NEOLINN300 mg in 1 PATCHPATCH3001
81816-001-01NEOLINN1 in 1 POUCHPATCH11
81816-001-30NEOLINN30 in 1 BOXPATCH301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81816-001NEOLINN (LIDOCAINE, MENTHOL) PATCH [REMY BIOSCIENCES, INC.]1Legacy NDC, 3 package rows20210605_562b5a21-d304-41d4-a52b-f12899daeecb.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81816-00181816-001-01, 81816-001-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
41511577-63e8-4773-a114-891e2caa95dd562b5a21-d304-41d4-a52b-f12899daeecb2021-06-02WarningsExact identifier
spl id: 41511577-63e8-4773-a114-891e2caa95dd
spl set id: 562b5a21-d304-41d4-a52b-f12899daeecb

Reported adverse events (FAERS/openFDA)#

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