NEOLINN- lidocaine, menthol patch

NEOLINN by

Drug Labeling and Warnings

NEOLINN by is a Otc medication manufactured, distributed, or labeled by REMY Biosciences, Inc., Blaine Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients:

Menthol 4%

Lidocaine 4%

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.

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.

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: support@neolinn.com

Manufactured for Neolinn, LLC by Remy Biosciences

17802  Sky Park Circle

Ste. 100

Irvine, CA 92614

Box

Pouch

res

INGREDIENTS AND APPEARANCE

NEOLINN 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81816-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	12 mg  in 300 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	12 mg  in 300 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81816-001-30	30 in 1 BOX	04/30/2021
1	NDC: 81816-001-01	1 in 1 POUCH
1		300 mg in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/30/2021

Labeler - REMY Biosciences, Inc. (117812858)

Registrant - REMY Biosciences, Inc. (117812858)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc		017314571	manufacture(81816-001)