FDA.reportPublic FDA data

Lidocaine

Manufacturer
Shinpharma Inc
Effective date
2024-04-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:10:40

Label at a glance#

ProductLidocaine
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%

Purpose

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, irritattion, 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 tightly 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, Lecithin, Propylene Glycol, Tocopheryl Acetate, Water

Questions or comments?

OTC - QUESTIONS SECTION

Contact our dedicated Customer Care at +1(877)786 2001 or email us at support@shinpharma.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Numb

Maximum Strength Pain Reliever

Prompt, Soothing Relief from Painful Burning, Itching and Discomfort

dr. numbdr. numb

dr. numb 2dr. numb 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1534792lidocaine 5 % Topical CreamPSN3
1534792lidocaine 50 MG/ML Topical CreamSCD3
1534792lidocaine 5 % Topical CreamSY3

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
69903-005-052024-04-03C16284748780-11030e365-59b8-111a-e063-dadaa90a10e2Dr. Numb Maximum Strength Pain Reliever
69903-005-052024-01-30C16284748780-11030e365-59b8-111a-e063-dadaa90a10e2Dr. Numb Maximum Strength Pain Reliever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69903-005-05Lidocaine50 g in 1 TUBECREAM503
69903-005-05Lidocaine1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69903-005LIDOCAINE (MAXIMUM STRENGTH PAIN RELIEVER) CREAM [SHINPHARMA INC]3Legacy NDC, 2 package rows20240405_cebc631c-b616-469e-e053-2995a90a6f74.zip

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
69903-00569903-005-05

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
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
LIDOCAINE98PI200987ACTIB
LECITHIN, SUNFLOWER834K0WOS5GIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZYL ALCOHOLLKG8494WBHIACT

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
153a53fb-65f1-545e-e063-6294a90ab208cebc631c-b616-469e-e053-2995a90a6f742024-04-03WarningsExact identifier
spl id: 153a53fb-65f1-545e-e063-6294a90ab208
spl set id: cebc631c-b616-469e-e053-2995a90a6f74

Reported adverse events (FAERS/openFDA)#

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