NEOLINN- lidocaine, menthol patch 
REMY Biosciences, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

NEOLINN Topical Pain Patch

Drug Facts

Active Ingredients:

Menthol 4%

Lidocaine 4%

Purpose:

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

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

Uses:

Temporarily relieves minor aches and muscle pains associated with

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

Warnings

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

    professional.

   • 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.

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

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

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

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: support@neolinn.com

Manufactured for Neolinn, LLC by Remy Biosciences

17802  Sky Park Circle

Ste. 100

Irvine, CA 92614

Box

Neolinn Label Box

Pouch

Inner Label

res

NEOLINN 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81816-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE12 mg  in 300 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL12 mg  in 300 mg
Inactive Ingredients
Ingredient NameStrength
CANNABIDIOL (UNII: 19GBJ60SN5)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (45/55 W/W; 100000 PA.S) (UNII: 5VBE2X0WG0)  
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S) (UNII: 9N5G1G3D3H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81816-001-3030 in 1 BOX04/30/2021
1NDC:81816-001-011 in 1 POUCH
1300 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/30/2021
Labeler - REMY Biosciences, Inc. (117812858)
Registrant - REMY Biosciences, Inc. (117812858)
Establishment
NameAddressID/FEIBusiness Operations
Blaine Labs Inc017314571manufacture(81816-001)

Revised: 6/2021
Document Id: 41511577-63e8-4773-a114-891e2caa95dd
Set id: 562b5a21-d304-41d4-a52b-f12899daeecb
Version: 1
Effective Time: 20210602
 
REMY Biosciences, Inc.