FDA.reportPublic FDA data

Curist Lidocaine Patch

Manufacturer
Little Pharma, Inc.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:21:28

Label at a glance#

ProductCurist Lidocaine Maximum Strength
Active ingredientLIDOCAINE
Label structure11 sections

Storage and handling

Other information store in a clean, dry place outside of direct sunlight protect product from excessive moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Lidocaine 4%

OTC - PURPOSE SECTION

Purpose

Topical Anesthetic

INDICATIONS & USAGE SECTION

Use

temporarily relieves minor pain

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on raw surfaces, blistered areas, wounds or other damaged skin
  • with a heating pad
  • more than one patch on your body at a time
  • with other topical anagesics

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • avoid contact with the eyes
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain, swelling, blistering or other irritation occurs where patch was applied
  • condition worsens
  • symptoms last more than 7 days
  • condition clears up and occurs again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and older:
  • clean and dry the affected area
  • open pouch and remove one patch
  • remove the protective backing from the patch starting at the corner
  • apply sticky side of patch to affected area
  • reseal pouch containing unused patches after each use
  • use one patch for up to 12 hours
  • discard patch after single use
  • children under 12 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store in a clean, dry place outside of direct sunlight
  • protect product from excessive moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients

Acrylic adhesive, alcohol, black pepper extract

OTC - QUESTIONS SECTION

Questions?

1-844-243-1241

SPL UNCLASSIFIED SECTION

Distributed by:

Little Pharma, Inc.

New York, NY 10023

Made in USA With Globally Sourced Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Curist

Lidocaine Patch Maximum Strength

Lidocaine 4% Patch

Topical Anesthetic

Temporary relief of pain: back, neck, shoulders, knees, elbows

20 PATCHES

3 in x 5 in (7.6 cm x 12.7 cm) each

Lidocaine Patch 01-2022Lidocaine Patch 01-2022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN4
1737778lidocaine 0.04 MG/MG Medicated PatchSCD4
1737778lidocaine 4 % Medicated PatchSY4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372559016192GTIN-13: 0372559016192
EAN-13: 0372559016192
GTIN-12: 372559016192
UPC-A: 372559016192
GTIN storage (14 digits): 00372559016192		Lidocaine Patch 01-2022.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72559-016-19Curist LidocaineMaximum Strength2.5 g in 1 PATCHPATCH2.54
72559-016-19Curist LidocaineMaximum Strength20 in 1 POUCHPATCH204

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72559-01672559-016-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BLACK PEPPERKM66971LVFIACT
ACRYLIC ACIDJ94PBK7X8SIACT
ALCOHOL3K9958V90MIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

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
Curist Lidocaine Maximum StrengthLIDOCAINELittle Pharma, Inc.d656135a-96da-1245-e053-2a95a90ac6262025-12-08WarningsExact identifier
ndc (package): 72559-016-19
ndc (product): 72559-016
ndc11 (package): 72559001619
spl id: 457635c7-dcd2-892c-e063-6294a90a9834
spl set id: d656135a-96da-1245-e053-2a95a90ac626

Reported adverse events (FAERS/openFDA)#

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