FDA.reportPublic FDA data

Dr. Numb

Manufacturer
Shinpharma Inc
Effective date
2026-04-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:55:48

Label at a glance#

ProductDr. Numb
Active ingredientLIDOCAINE
Label structure12 sections

Indications and uses

For temporary relief of local discomfort, itching, soreness or burning in the perianal area associated with anorectal disorders

Dosage and administration

Adults and children 12 years and older: 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 to the affected area up to 6 times a day. Children under 12 years: Consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purposes

OTC - PURPOSE SECTION

Anorectal (Hemorrhoidal)

Uses

INDICATIONS & USAGE SECTION

For temporary relief of local discomfort, itching, soreness or burning in the perianal area associated with anorectal disorders

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • allergic reaction occurs
  • rectal bleeding occurs
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • condition worsens or does not improve within 7 days

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: 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 to the affected area up to 6 times a day.

Children under 12 years: Consult a doctor

Other information

OTHER SAFETY INFORMATION

  • always keep the tube tighlty closed
  • store at temperatures not exceeding 15°C-30°C (59°F - 86°F)
  • protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbopol, Letcithin, Propylene Glycol, Tocopheryl Acetate, Water

Questions?

OTC - QUESTIONS SECTION

Contact our dedicated Customer Care at + (877) 786 2001 or email us at support@shinpharma.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Numb

Maximum Strength Pain Reliever

2 oz | ml

picpic

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366794Dr. Numb 5 % Rectal CreamPSN4
1366789lidocaine 5 % Rectal CreamPSN4
1366794lidocaine 50 MG/ML Rectal Cream [Dr. Numb]SBD4
1366789lidocaine 50 MG/ML Rectal CreamSCD4
1366794Dr. Numb 5 % Rectal CreamSY4
1366794Dr. Numb 50 MG/ML Rectal CreamSY4
1366789lidocaine 5 % Rectal CreamSY4

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
69903-006-022024-04-03C16284748780-11030e365-053c-111a-e063-dadaa90a10e2Dr. Numb
69903-006-022024-01-30C16284748780-11030e365-053c-111a-e063-dadaa90a10e2Dr. Numb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69903-006-02Dr. Numb60 mL in 1 CONTAINERCREAM604
69903-006-02Dr. Numb1 in 1 CARTONCREAM14

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69903-00669903-006-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BENZYL ALCOHOLLKG8494WBHIACT
LIDOCAINE98PI200987ACTIB
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
Dr. NumbLIDOCAINEShinpharma Ince840fba4-86ff-9da0-e053-2995a90a221a2026-04-30WarningsExact identifier
ndc (package): 69903-006-02
ndc (product): 69903-006
ndc11 (package): 69903000602
spl id: 50b51229-4339-688d-e063-6394a90a7961
spl set id: e840fba4-86ff-9da0-e053-2995a90a221a

Reported adverse events (FAERS/openFDA)#

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