FDA.reportPublic FDA data

Numb 520

Manufacturer
Clinical Resolution Laboratory, Inc.
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:05:46

Label at a glance#

ProductNumb 520
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

For the temporary relief of local and anorectal dicomfort associated with anorectal discomfort or inflammation.

Dosage and administration

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply up to 6 times a day. Children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of local and anorectal dicomfort associated with anorectal discomfort or inflammation.

Warnings

WARNINGS SECTION

(For external use only)

Do not use this product if

OTC - DO NOT USE SECTION

  • Pregnant or breast-feeding, ask a health professional before use.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately.
  • Tamper Evident "Warranty Void...Seal...label atop the container is broken."

When using this product

OTC - WHEN USING SECTION

  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • Certain persons can develop allergic reactions to ingredients in this product.
  • Do not put this product into the rectum by using fingers or any medical device or applicator.

Stop use and ask a doctor if

OTC - STOP USE SECTION

The symptom being treated does not subside or if redness, irritation, swellinh, pain, or other symptoms develop or increase.    

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical attention immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Apply up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • Keep away from direct sunlight or heat
  • Store in room temperature (59-860F / 15-300C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ehtoxydiglycol, Lecithin, Neopentyl Glycol Dicarprylate/Dicarpate, Sodiuym Polyacrylate, Hydrogenated Polydecene, Trideceth-10, Cholesterol, Allantoin, Benzyl Alcohol, Tocopherol Acetate, Polysorbate-80

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OuterOuter

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
63742-002-01Numb 52038 g in 1 BOTTLECREAM384
63742-002-01Numb 5201 in 1 PACKAGECREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63742-002NUMB 520 (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]4Legacy NDC, 2 package rows20231227_f88829f2-d900-4b78-b2cc-eebd76c326cd.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63742-00263742-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZYL ALCOHOLLKG8494WBHIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
NEOPENTYL GLYCOL DICAPRATE77T908SE82IACT
TRIDECETH-10G624N6MSBAIACT
CHOLESTEROL97C5T2UQ7JIACT
ALLANTOIN344S277G0ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 806OZP39ZG8HIACT
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
0d762cea-b5e1-6ff1-e063-6394a90aee03f88829f2-d900-4b78-b2cc-eebd76c326cd2023-12-26WarningsExact identifier
spl id: 0d762cea-b5e1-6ff1-e063-6394a90aee03
spl set id: f88829f2-d900-4b78-b2cc-eebd76c326cd

Reported adverse events (FAERS/openFDA)#

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