UBER NUMB TOPICAL ANESTHETIC (LIDOCAINE HYDROCHLORIDE) CREAM [UBERSCIENTIFIC, LLC]

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UBER NUMB TOPICAL ANESTHETIC (LIDOCAINE HYDROCHLORIDE) CREAM [UBERSCIENTIFIC, LLC]
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NDC 71131-797-04
Set ID 4939a547-c94b-3350-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager UberScientific, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
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  • DRUG FACTS:

  • Active Ingredient:

    Lidocaine HCl 5.00% 

    External analgesic

  • Uses:

    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.

    When using this product,

    • do not exceed the recommended daily dosage unless directed by a doctor.
    • Do not insert this product into rectum using fingers or any mechanical device.

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

    Keep out of reach of children.

    • Keep out of reach of children.
  • Directions:

    Children under 12, consult a doctor

    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.

  • Other Ingredients:

    Allantoin Gel, Deionized Water, Benzyl Alcohol, Carbomer, Propylene
    Glycol, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E),
    Triethanolamine

  • Other Information

    Store at room temperature. Avoid Direct Sunlight. Do not use if
    tamper evident packaging has been breached or is missing.

    Distributed by:

    UberScientific LLC
    838 E High St - Ste 271
    Lexington, KY 40502

  • Package Labeling:

    4oz Label

  • INGREDIENTS AND APPEARANCE
    UBER NUMB TOPICAL ANESTHETIC 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71131-797
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71131-797-04118 mL in 1 JAR; Type 0: Not a Combination Product02/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/23/2017
    Labeler - UberScientific, LLC (080459429)
    Registrant - UberScientific, LLC (080459429)
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