FDA.reportPublic FDA data

Numbskin Maximum Strength Pain Reliever

Manufacturer
Shinpharma Inc
Effective date
2024-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:00

Label at a glance#

ProductNumbskin Maximum Strength Pain Reliever
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

NDC 69903-007-02

Numbskin Maximum Strength Pain Reliever

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN1
1366789lidocaine 50 MG/ML Rectal CreamSCD1
1366789lidocaine 5 % Rectal CreamSY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69903-007-02Numbskin Maximum Strength Pain Reliever60 mL in 1 CONTAINERCREAM601
69903-007-02Numbskin Maximum Strength Pain Reliever1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69903-007NUMBSKIN MAXIMUM STRENGTH PAIN RELIEVER (LIDOCAINE) CREAM [SHINPHARMA INC]12 package rows20240829_20c228c8-f2e9-8b8d-e063-6294a90ae327.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
69903-00769903-007-02

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
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
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
20c21167-75ff-6d18-e063-6394a90a172f20c228c8-f2e9-8b8d-e063-6294a90ae3272024-08-28WarningsExact identifier
spl id: 20c21167-75ff-6d18-e063-6394a90a172f
spl set id: 20c228c8-f2e9-8b8d-e063-6294a90ae327

Reported adverse events (FAERS/openFDA)#

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