FDA.reportPublic FDA data

Quick Numb

Manufacturer
Clinical Resolution Laboratory, Inc.
Effective date
2022-07-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:07

Label at a glance#

ProductQuick Numb
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation For the temporary relief of pain, burning and soreness.

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. Children under 12 years of age: consult a doctor. Apply externally to the affected area up to 6 times daily.

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 itching and discomfort associated with anorectal disorders and anorectal inflammation
  • For the temporary relief of pain, burning and soreness.

Warnings

WARNINGS SECTION

  • If condition worsens or does not improve within 7 days, consult a doctor.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • In case of bleeding, consult a doctor promptly.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
  • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

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. Children under 12 years of age: consult a doctor.
  • Apply externally to the affected area up to 6 times daily.

Other Information

SPL UNCLASSIFIED SECTION

  • Keep away from direct sunlight or heat.
  • Store at room temperature 15°-30°C (59°-86°F).
  • This package is child-resistant. Keep out of reach of children.
  • In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
  • Do not use this product if seal is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allanloin, Aloe Barbadensis Leaf Juice, Benzyt Alcohol,Carbomer, Cholesterol, Dlmethyt lsosorbide, DisodiumEDTA, Hydrogenated Polydecene, Lecithin, NeopenlytGlycol Dicaprylale/Dicaprate. Propylene Glycol, Water,Sodium Polyacrytate, Tocopheryt Acetate, Trideceth-6,Triethanolamine

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN2
1366789lidocaine 50 MG/ML Rectal CreamSCD2
1366789lidocaine 5 % Rectal CreamSY2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63742-110-012024-01-30C16284748780-11030e365-0301-111a-e063-dadaa90a10e2f155d10c-158d-4380-a258-e50879254440

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63742-110-01Quick Numb35.43 g in 1 BOTTLECREAM35.432

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63742-110QUICK NUMB (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]2Legacy NDC, 1 package rows20220710_f155d10c-158d-4380-a258-e50879254440.zip

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
63742-11063742-110-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CHOLESTEROL97C5T2UQ7JIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYDROGENATED POLYDECENE (1500 CST)4YI0729529IACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEVLW429K27KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECETH-63T5PCR2H0CIACT
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
e3513760-de70-3494-e053-2a95a90a64a7f155d10c-158d-4380-a258-e508792544402022-07-08WarningsExact identifier
spl id: e3513760-de70-3494-e053-2a95a90a64a7
spl set id: f155d10c-158d-4380-a258-e50879254440

Reported adverse events (FAERS/openFDA)#

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