FDA.reportPublic FDA data

Point Relief LidoSpot ​™ ​ Patch

Manufacturer
Fabrication Enterprises
Effective date
2017-12-29
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-02 01:05:35

Label at a glance#

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

Indications and uses

For temporary relief of pain and itching associated with minor burns, cuts, scrapes and minor skin irritations.

Dosage and administration

Apply to treatment area. How to apply: Clean and dry treatment area. If customized size is needed, cut patch to the desired size/shape with scissors. Remove protective backing from patch to expose active ingredient and adhesive. Apply patch to treatment area. Use only one patch at a time. Use a maximum of four patches per day. Leave patch on treatment area for up to 12 hours. Do not use patches for longer than 5 c...

Storage and handling

Store at room temperature Avoid direct sunlight

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Menthol 1%

OTC - PURPOSE SECTION

Topical Anesthetic

External Anesthetic

USES

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with minor burns, cuts, scrapes and minor skin irritations.

WARNINGS

WARNINGS SECTION

  • For External use only. Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • If symptoms persist for more than 7 days, discontinue use and consult a physician
  • If swallowed, consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. Consult a physician prior to using on children under 12.

OTC - DO NOT USE SECTION

  • Do not apply to open wounds or damaged skin.
  • Do not use oils, lotions or powders on treatment area prior to application.
  • Do not use with any bandage, wrap, stocking or similar device or garment.

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If pregnant or breast feeding, contact a physician prior to use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply to treatment area.
  • How to apply:
  • Clean and dry treatment area.
  • If customized size is needed, cut patch to the desired size/shape with scissors.
  • Remove protective backing from patch to expose active ingredient and adhesive.
  • Apply patch to treatment area.
  • Use only one patch at a time. Use a maximum of four patches per day.
  • Leave patch on treatment area for up to 12 hours.
  • Do not use patches for longer than 5 consecutive days.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Glycerol, Sodium polyacrylate, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Aluminiumglycinate, Titaniumdioxide, Kaolin, Tween 80, Propylene glycol, Tartaric acid, PVP, Polyacrylic acid, Methylparaben, Propylparaben.

STORAGE AND HANDLING SECTION

Store at room temperature

Avoid direct sunlight

Representative Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LidoSpotLidoSpot

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51452-727-012022-01-18C16284748780-19d75b9cf-eba0-f424-e053-dadaa90a57cePoint Relief LidoSpot ​™ ​ Patch
51452-727-012020-01-31C16284748780-19d75b9cf-eba0-f424-e053-dadaa90a57cePoint Relief LidoSpot ​™ ​ Patch

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51452-72751452-727-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
METHYLPARABENA2I8C7HI9TIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
GLYCERINPDC6A3C0OXIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
TARTARIC ACIDW4888I119HIACT
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE)9Q5W5G6461IACT
POLYSORBATE 806OZP39ZG8HIACT
KAOLIN24H4NWX5COIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
PROPYLPARABENZ8IX2SC1OHIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
07414112-bec7-2e9a-e063-6294a90a32597107e22e-9332-4509-b368-32296acb56482023-10-08WarningsExact identifier
spl set id: 7107e22e-9332-4509-b368-32296acb5648

Reported adverse events (FAERS/openFDA)#

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