FDA.reportPublic FDA data

Base Numb Topical Anorectal Cream

Manufacturer
Joonem LLC
Effective date
2021-07-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:40:35

Label at a glance#

ProductBase Numb Topical Anorectal
Active ingredientLIDOCAINE
Label structure6 sections

Dosage and administration

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 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 ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Indications:

INDICATIONS & USAGE SECTION

For the temporary relief of pain and discomfort associated with anorectal disorders

Warnings:

WARNINGS SECTION

  • If condition worsens or does not improve within 7 days, consult a doctor.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • In case of bleeding, consult a doctor promptly.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
  • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other, symptoms develop or increase, discontinue use and consult a doctor.

Keep out of reach of children to avoid accidental ingestion!

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply externally to the affected area up to 6 times daily.
  • Children under 12 years of age:
  • consult a doctor

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Vera, Chamomile, Tea Trea Oil, Clove Oil, Hemp Seed Oil, Glycerin, Stearic Acid, EDTA, Arcel 165, Carbopol U-10, Cetyl Alcohol, BHT, Cetearyl Alcohol, Cetearyl Glucoside, Phenoxyethanol, Ethylhexylglycerin, Cyclopentasiloxane, Phenyl Trimethicone, Dimethiconol, C12-15 Alkyl Benzoate, Dimethicone Crosspolymer, Caustic Soda/Sodium Hydroxide, Capric Caprylic Triglyceride, DM Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel
label2label2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80327-000-012024-01-02C16284748780-1e4f33bdf-b20b-d8a0-e053-dadaa90a6e4eBase Numb Topical Anorectal Cream
80327-000-012022-07-29C16284748780-1e4f33bdf-b20b-d8a0-e053-dadaa90a6e4eBase Numb Topical Anorectal Cream

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80327-00080327-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CHAMOMILEFGL3685T2XIACT
CLOVE OIL578389D6D0IACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
EDETIC ACID9G34HU7RV0IACT
CETYL ALCOHOL936JST6JCNIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
TEA TREE OILVIF565UC2GIACT

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
0df9470c-e604-6f4c-e063-6394a90ad4c9aee45b4b-1b21-10c6-e053-2a95a90a19602024-01-02WarningsExact identifier
spl set id: aee45b4b-1b21-10c6-e053-2a95a90a1960

Reported adverse events (FAERS/openFDA)#

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