FDA.reportPublic FDA data

NUMB CREAM

Manufacturer
Gabar Health Sciences Corp.
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:23:33

Label at a glance#

ProductNUMB
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

For the temporary roliot of local and anorectal discomfort associated with anorectal disorder or inflammation.

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 toilet tissue or a soft cloth before application of this product. Apply up to 6 times a day. Children un 12 years of age consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% W/W

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary roliot of local and anorectal discomfort associated with anorectal disorder or inflammation.

Warnings (For external use only)

WARNINGS SECTION

Do not use this product if

  • Pregnant or breastfeeding, ask a health professional before use.
  • In case of accidental overdose, get medical help or contact Poison Control Center immediately.
  • tamper evident "Do not use this product" If seal is broken or missing.

When using this product

  • do not exceed the recommended daily dosage unless directed by doctor.
  • Certain persons can develop allergic reactions to ingredients in this product.
  • Do not put this product into the rectum by using ‑nger or any medical device or applicator.

Stop use and ask doctor if

the symptoms being treated does not subside, or if redness, Irritation, swelling pain or other symptoms develop or increase.

Keep out of reach of the children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, sook modical attention immediately.

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 toilet tissue or a soft cloth before application of this product.
  • Apply up to 6 times a day.
  • Children un 12 years of age consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

• Keep away from direct sunlight or heat.

• Store at room temperature 15° to 30°C (59° to 86°F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purfied Water, Trolamine, Vitamin E Acetate

Questions ?

SPL UNCLASSIFIED SECTION

(407) 737-9424

Principal Primary Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NUMB CREAM

NDC 82429-203-01

Lidocaine Cream 5%

NET WT 1.35 OZ (38g)

labellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82429-203NUMB (LIDOCAINE 5%) CREAM [GABAR HEALTH SCIENCES CORP.]5Legacy NDC20231022_a3ae5f00-01f4-4a8d-8dbf-cb1f930a8146.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82429-203-01GM - Gram82429-2030b796cf4-29d6-4052-9a7f-76560c756b8d12022-11-07

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82429-20382429-203-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
TROLAMINE9O3K93S3TKIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POLYSORBATE 806OZP39ZG8HIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHOLESTEROL97C5T2UQ7JIACT
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
4c2e0097-c16a-8eee-e063-6394a90a78b9a3ae5f00-01f4-4a8d-8dbf-cb1f930a81462026-03-04WarningsExact identifier
spl set id: a3ae5f00-01f4-4a8d-8dbf-cb1f930a8146

Reported adverse events (FAERS/openFDA)#

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