Neolinn
FDA Label NDC 81816-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Remy Biosciences, Inc. for the product Neolinn (NDC 81816-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Active Ingredient

Active Ingredients:

Menthol 4%

Lidocaine 4%

Otc - Purpose

Purpose:

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

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

Indications & Usage

Uses:

Temporarily relieves minor aches and muscle pains associated with

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

Warnings

Warnings

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

    professional.

Otc - Do Not Use

   • 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

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

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

Dosage & Administration

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

Other Ingredients:

Presure Sensitive Adhesive, Cannabidiol (Hemp Extract), Diethylene

Glycol Monoethyl Ether, Vitamin C [as Ascorbyl Palmitate]

Package Labeling

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: [email protected]

Manufactured for Neolinn, LLC by Remy Biosciences

17802  Sky Park Circle

Ste. 100

Irvine, CA 92614

Box

Pouch

res

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