Label: NEOLINN- lidocaine, menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 81816-001-01, 81816-001-30 - Packager: REMY Biosciences, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 2, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
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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
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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
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INGREDIENTS AND APPEARANCE
NEOLINN
lidocaine, menthol patchProduct 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)