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

UBER NUMB TOPICAL ANESTHETIC (LIDOCAINE HYDROCHLORIDE) CREAM [UBERSCIENTIFIC, LLC]
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NDC 71131-774-01
Set ID 441c802f-a363-1530-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager UberScientific, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
  • DRUG FACTS:
  • Active Ingredient:

    Lidocaine HCl 5.00%

    Local Anesthetic

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  • Uses:

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

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  • Warnings:

    • For external use only. Use only as directed. 

    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.

    Keep out of reach of children.

    Children under 12 should consult physician prior to use.

    Stop using this product if:

    • Symptoms worsen or does not improve within seven days
    • Bleeding occurs. Redness, irritation, swelling, pain or other symptoms develop.
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  • Directions:

    • Adults and children 12-years and over: apply to affected area.
    • Children under 12, consult a physician before use.
    • How to Apply:
    • Clean affected area with warm water nad mild soap. Rinse thoroughly.
    • Gently dry by patting with toilet tissue or soft cloth.
    • Apply externally to area up to six times per day.
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  • Other Ingredients:

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

    • Store at room temperature. Avoid direct sunlight
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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    UBER NUMB TOPICAL ANESTHETIC 
    lidocaine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71131-774
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71131-774-01 28.35 g in 1 JAR; Type 0: Not a Combination Product 12/20/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 12/20/2016
    Labeler - UberScientific, LLC (080459429)
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