FDA.reportPublic FDA data

Numb Skin

Manufacturer
Seenext Venture Ltd
Effective date
2022-11-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:51:28

Label at a glance#

ProductNumb Skin
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

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

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 tissue or a soft cloth before application of product. when first opening the tube, puncture foil seal with top end of cap apply externally to the affected area up to 6 times daily children under 12 years of age: consult a doctor

Storage and handling

always keep the tube tightly closed store at temperatures not exceeding 15 O C - 30 O C protect from freezing

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Anorectal (Hemmorhoidal)

Uses

INDICATIONS & USAGE SECTION

For temporary relief of local discomfort, itching, pain, 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 the use and consult doctor if:

OTC - STOP USE SECTION

  • allergic reaction occurs
  • rectal bleeding occurs
  • redness, irritation, swelling, pain, or other symptoms begin or increase
  • condition worsenss 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: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally to the affected area up to 6 times daily
  • children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • always keep the tube tightly closed
  • store at temperatures not exceeding 15 OC - 30 OC
  • protect from freezing

Inactive ingrdients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbomer 934, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Water

Question or comments

OTC - QUESTIONS SECTION

Call weekdays 9 AM to 6 PM PST at 1-844-700-6862 or email us at support@numbskin.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70907-001-15

FOR EXTERNAL USE ONLY

NumbSkin Cream ®

5% Lidocaine Cream

Maximum Strength Pain Reliever

NET WT. 15g

LabelLabel

NDC 70907-001-30

FOR EXTERNAL USE ONLY

NumbSkin Cream ®

5% Lidocaine Cream

Maximum Strength Pain Reliever

NET WT. 30g

Label 1Label 1

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
70907-001-152024-01-30C16284748780-11030e365-1e53-111a-e063-dadaa90a10e2Drug Facts
70907-001-302024-01-30C16284748780-11030e365-1e53-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70907-001-15Numb Skin15 g in 1 TUBECREAM158
70907-001-15Numb Skin1 in 1 CARTRIDGECREAM18
70907-001-30Numb Skin1 in 1 CARTRIDGECREAM18
70907-001-30Numb Skin30 g in 1 TUBECREAM308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70907-001NUMB SKIN (LIDOCAINE CREAM) CREAM [SEENEXT VENTURE LTD]8Legacy NDC, 4 package rows20221110_3ac18167-774b-3777-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70907-00170907-001-30, 70907-001-15

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 934Z135WT9208IACT
PROPYLENE GLYCOL BUTYL ETHER6X8776AP5ZIACT
TOCOPHERYL RETINOATE0WN694NBMMIACT
BENZYL ALCOHOLLKG8494WBHIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML · Source PDF

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
ed0f3275-f159-13a3-e053-2a95a90a2ce83ac18167-774b-3777-e054-00144ff8d46c2022-11-09WarningsExact identifier
spl id: ed0f3275-f159-13a3-e053-2a95a90a2ce8
spl set id: 3ac18167-774b-3777-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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