Label: INKEEZE ORIGINAL B NUMB CYLINDER- lidocaine gel

  • 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 August 12, 2021

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  • DRUG FACTS

  • ACTIVE INGREDIENTS:

    Lidocaine 5%

    PURPOSE:

    Topical Anesthetic

  • USES:

    External Use Only: For the temporary relief of local itching and discomfort in the perianal area.

  • INACTIVE INGREDIENTS:

    Alcohol, Benzyl Alcohol Carbomer, Citric Acid, Ethoxydiglycol, Propylene Glycol, Purified Water.

  • DIRECTIONS:

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

  • WARNINGS

    KEEP OUT OF REACH OF CHILDREN

    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 symptoms being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

    WHEN USING THIS PRODUCT:

    you may notice temporary blanching or redness of the skin where gel is applied.

  • CONTACT:

    1-800-611-7720 www.inkeeze.com

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    INKEEZE ORIGINAL B NUMB CYLINDER 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82022-001
    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
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82022-001-0029.5 mL in 1 TUBE; Type 0: Not a Combination Product08/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/12/2021
    Labeler - Indelicare, LLC (118075123)
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