FDA.reportPublic FDA data

Curist Lidocaine Numbing Relief

Manufacturer
Little Pharma, Inc.
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:38:29

Label at a glance#

ProductCurist Lidocaine Numbing Relief
Active ingredientLIDOCAINE
Label structure11 sections

Storage and handling

Other information Store at 15-30°C (59-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Lidocaine 5%

OTC - PURPOSE SECTION

Purpose

Anorectal (hemorrhoidal) cream

INDICATIONS & USAGE SECTION

Uses

Helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes.
  • do not exceed recommended dosage unless directed by a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rectal bleeding occurs.
  • condition worsens or does not improve within 7 days.
  • allergic reaction occurs to ingredients in this product.
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
  • symptoms clear up and return 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

  • When practical, clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

STORAGE AND HANDLING SECTION

Other information

Store at 15-30°C (59-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients Benzyl alcohol, carbomer, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, triethanolamine, water.

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 Numbing Relief

Lidocaine 5% Cream

Anorectal (Hemorrhoidal) Cream

Relief of Pain, Itching and Burning

Net. Wt. 6 oz (170 g)

Lidocaine CreamLidocaine Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN5
1366789lidocaine 50 MG/ML Rectal CreamSCD5
1366789lidocaine 5 % Rectal CreamSY5

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72559-012-08Curist Lidocaine Numbing Relief170 g in 1 TUBECREAM1705
72559-012-15Curist Lidocaine Numbing Relief170 g in 1 TUBECREAM1705
72559-012-15Curist Lidocaine Numbing Relief1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72559-012CURIST LIDOCAINE NUMBING RELIEF (LIDOCAINE) CREAM [LITTLE PHARMA, INC.]5Current NDC, Legacy NDC, 3 package rows20241122_bff3c422-a0df-6196-e053-2a95a90af033.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72559-01272559-012-08, 72559-012-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZYL ALCOHOLLKG8494WBHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHOLESTEROL97C5T2UQ7JIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
TROLAMINE9O3K93S3TKIACT
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 Numbing ReliefLIDOCAINELittle Pharma, Inc.bff3c422-a0df-6196-e053-2a95a90af0332024-11-20WarningsExact identifier
ndc (package): 72559-012-15
ndc (package): 72559-012-08
ndc (product): 72559-012
ndc11 (package): 72559001208
ndc11 (package): 72559001215
spl id: 275eed5c-d898-6b17-e063-6294a90a03a7
spl set id: bff3c422-a0df-6196-e053-2a95a90af033

Reported adverse events (FAERS/openFDA)#

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