Label: BASE NUMB TOPICAL ANORECTAL- lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 15, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Lidocaine 5%

    Purpose

    Topical Analgesic

  • Indications:

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

  • Warnings:

    • 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!

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

  • Directions:

    • 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:

    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:

    Label
    label2

  • INGREDIENTS AND APPEARANCE
    BASE NUMB TOPICAL ANORECTAL 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80327-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CLOVE OIL (UNII: 578389D6D0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80327-000-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/01/2020
    Labeler - Joonem LLC (117633878)