Point Relief LidoSpot with Menthol

Manufacturer
Fabrication Enterprises | Foshan Aqua Gel Biotech Co.,Ltd.
Effective date
2025-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:28:56

Label at a glance#

ProductPoint Relief LidoSpot with Menthol
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

Temporary relief of minor pain

Dosage and administration

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard after single use. Children under 12 years of age: consult a physician.

Storage and handling

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% Topical Anesthetic

Menthol 1% Topical Anesthetic

OTC - PURPOSE SECTION

Topical Anesthetic

USES

INDICATIONS & USAGE SECTION

Temporary relief of minor pain

WARNINGS

WARNINGS SECTION

  • For External use only. Use only as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - DO NOT USE SECTION

■ More than one patch on your body at a time

■ On cut, irritated or swollen skin

■ On puncture wounds

■ For more than one week without consulting a doctor

■ If you are allergic to any active or inactive ingredients

■ If pouch is damaged or opened.

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • Contact a physician prior to use.

WHEN USING:

OTC - WHEN USING SECTION

■ Use only as directed

■ Read and follow all directions and warnings on this carton

■ Do not allow contact with the eyes

■ Do not use at the same time as other topical analgesics

■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ Do not microwave

■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain
the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor if

OTC - STOP USE SECTION

■ Condition worsens

■ Redness is present

■ Irritation develops

■ Symptoms persist for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

DIRECTIONS Adults and children 12 years of age and over:

DOSAGE & ADMINISTRATION SECTION

Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side
of patch to affected area. Use one patch for up to 12 hours. Discard after single use.
Children under 12 years of age: consult a physician.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol,
propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

STORAGE AND HANDLING SECTION

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Manufactured For: Fabrication Enterprises Inc White Plains, NY 10602 www.FabEnt.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LidoSpot with MentholLidoSpot with Menthol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN3
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD3
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51452-912-052025-12-28C16284748780-12cef2736-b01e-d83d-e063-dadaa90ab31fPoint Relief LidoSpot with Menthol
51452-912-052025-01-30C16284748780-12cef2736-b01e-d83d-e063-dadaa90ab31fPoint Relief LidoSpot with Menthol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51452-912-05Point Relief LidoSpot with Menthol8 g in 1 PATCHPATCH83
51452-912-05Point Relief LidoSpot with Menthol5 in 1 POUCHPATCH53

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51452-91251452-912-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML · Source PDF

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
Point Relief LidoSpot with MentholLIDOCAINE, MENTHOLFabrication Enterprisesf0c69693-bfea-4006-9620-63b222d25d382025-12-28WarningsExact identifier
ndc (package): 51452-912-05
ndc (product): 51452-912
ndc11 (package): 51452091205
spl id: 47061346-aa5f-1a85-e063-6294a90afd0a
spl set id: f0c69693-bfea-4006-9620-63b222d25d38

Reported adverse events (FAERS/openFDA)#

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