Label: ADVANCED NUMB TOPICAL ANESTHETIC- lidocaine hydrochloride cream

  • NDC Code(s): 71131-052-02, 71131-052-04
  • Packager: Uber Scientific, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • DRUG FACTS

  • Active Ingredients

    Lidocaine HCL (5%)

    Purpose

    External Analgesic

  • Use

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

  • Warnings

    For external use only. 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.

    Keep out of reach of children.

    If swallowed, get medical help or contact the Poison Control Center immediately.

  • Directions

    Adults and children 12 years and older:  For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product.

    Apply externally up to 6 times per day.

    Children under 12: Consult a Doctor.

  • Inactive ingredients

    Allantoin Gel, Deionized Water, Benzyl Alcohol, Carbomer, Pro-pylene GLycol, Sodim Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine

  • Other Information

    Store at room temperature. Avoid Direct sunlight.

  • Package Labeling:

    Jar

  • INGREDIENTS AND APPEARANCE
    ADVANCED NUMB TOPICAL ANESTHETIC 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71131-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71131-052-0257 g in 1 JAR; Type 0: Not a Combination Product04/20/201812/31/2020
    2NDC:71131-052-04114 g in 1 JAR; Type 0: Not a Combination Product04/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01504/20/2018
    Labeler - Uber Scientific, LLC (080459429)
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