FDA.reportPublic FDA data

Topical Anesthetic Anorectal Cream

Manufacturer
Dermtech Labs Inc. dba GD Labs | VEGE-KURL, INC
Effective date
2017-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:22

Label at a glance#

ProductTopical Anesthetic Anorectal Cream Numb and Number
Active ingredientLIDOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient     Purpose
Lidocaine 5%  ..... Topical Anesthetic

OTC - PURPOSE SECTION

Temporarily relieves local pain and discomfort of anorectal area.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Chilren

INDICATIONS & USAGE SECTION

Stop use and ask your doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days.

WARNINGS SECTION

  • For Rectal use only
  • For external use on intact skin only
  • Do not use if pregnant or breast-feeding
  • Do not exceed the recommended daily dosage unless directded by a doctor
  • Avoid contact with eyes and mucous membranes
  • You may experience temporary redness or stinging where the product is applied
  • If irritation persists, consult your doctor
  • Do not put product into the rectum by using fingers or any mechanical device or applicator

DOSAGE & ADMINISTRATION SECTION

  • Children 12 and under, consult a physician prior to use
  • When practical, clean area with mild soap and water. Rinse thoroughly and gently dry by blotting with tissue or soft cloth before applying.
  • Apply to the affected area up to 6 times daily

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ceteareth-20, Cetearyl Alcohol, Cholesterol, Ethoxydiglycol, Lecithin, Polysorbate-80, PPG-12/SMDI Copolyme, Propylene Glycol, Trolamine, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Numb & Number

Topical Anesthetic

Anorectal Cream

Net Wt 20 oz / 600g

labellabel

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68848-001-022020-01-31C16284748780-19d75b9d0-18a9-f424-e053-dadaa90a57ceNumb & Number - Topical Anesthetic anorectal cream
68848-001-042020-01-31C16284748780-19d75b9d0-18a9-f424-e053-dadaa90a57ceNumb & Number - Topical Anesthetic anorectal cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68848-001-01Topical Anesthetic Anorectal CreamNumb and Number54 g in 1 PACKAGECREAM542
68848-001-02Topical Anesthetic Anorectal CreamNumb and Number1 in 1 PACKAGECREAM12
68848-001-03Topical Anesthetic Anorectal CreamNumb and Number600 g in 1 PACKAGECREAM6002
68848-001-04Topical Anesthetic Anorectal CreamNumb and Number1 in 1 PACKAGECREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68848-001TOPICAL ANESTHETIC ANORECTAL CREAM NUMB AND NUMBER (LIDOCAINE) CREAM [DERMTECH LABS INC. DBA GD LABS]2Legacy NDC, 4 package rows20170106_1a99fa0e-a6c2-499f-81d4-79e2d052ff74.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68848-00168848-001-01, 68848-001-02, 68848-001-03, 68848-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
BENZYL ALCOHOLLKG8494WBHIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHOLESTEROL97C5T2UQ7JIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
POLYSORBATE 806OZP39ZG8HIACT
PPG-12/SMDI COPOLYMER1BK9DDD24EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
578120ea-8e99-4f6d-9737-bf5251a102881a99fa0e-a6c2-499f-81d4-79e2d052ff742017-01-03WarningsExact identifier
spl id: 578120ea-8e99-4f6d-9737-bf5251a10288
spl set id: 1a99fa0e-a6c2-499f-81d4-79e2d052ff74

Reported adverse events (FAERS/openFDA)#

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