FDA.reportPublic FDA data

NUMB PLUS Maximum Strength Anorectal Cream

Manufacturer
SEENEXT VENTURE LTD
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:01:57

Label at a glance#

ProductNUMB PLUS Maximum Strength Anorectal
Active ingredientLIDOCAINE
Label structure8 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 jar, twist the cap and peel off the foil seal apply externally to the affected area up to 6 times daily children under 12 years of age: consult a doctor 

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5.00%

Purpose

OTC - PURPOSE SECTION

Anorectal (Hermorrhoidal)

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 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

If pregnant or breastfeeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use   

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 jar, twist the cap and peel off the foil seal
  • apply externally to the affected area up to 6 times daily
  • children under 12 years of age: consult a doctor 

Other Information

SPL UNCLASSIFIED SECTION

  • always keep the jar tightly closed
  • protect from freezing
  • store at room temperatures not exceeding 59°F to 86°F (15°C to 30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Dodecane, Ethylhexylglycerin, Lecithin, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70907-098-60NUMB PLUS Maximum Strength Anorectal1 in 1 BOXGEL14
70907-098-60NUMB PLUS Maximum Strength Anorectal60 mL in 1 JARGEL604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70907-098NUMB PLUS MAXIMUM STRENGTH ANORECTAL (LIDOCAINE) GEL [SEENEXT VENTURE LTD]4Current NDC, Legacy NDC, 2 package rows20231114_a7c37b2a-b647-43d7-b43b-87bbece35430.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70907-09870907-098-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
DODECANE11A386X1QHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TROLAMINE9O3K93S3TKIACT
CORN0N8672707OIACT
PROPANEDIOL5965N8W85TIACT
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
NUMB PLUS Maximum Strength AnorectalLIDOCAINESEENEXT VENTURE LTDa7c37b2a-b647-43d7-b43b-87bbece354302023-11-05WarningsExact identifier
ndc (package): 70907-098-60
ndc (product): 70907-098
ndc11 (package): 70907009860
spl id: 09745e88-e706-aa2c-e063-6394a90a954f
spl set id: a7c37b2a-b647-43d7-b43b-87bbece35430

Reported adverse events (FAERS/openFDA)#

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