NUMQUICK TOPICAL ANALGESIC (EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [UNIT DOSE, LTD.]

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NUMQUICK TOPICAL ANALGESIC (EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [UNIT DOSE, LTD.]
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NDC 67194-005-01
Set ID 3f64cbd3-6745-4397-9767-3adc3b301e0e
Category HUMAN OTC DRUG LABEL
Packager Unit Dose, Ltd.
Generic Name
Product Class alpha-Adrenergic Agonist, Amide Local Anesthetic, Antiarrhythmic, beta-Adrenergic Agonist
Product Number
Application Number PART346
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  • Drug Facts

  • Active ingredient

    (-) Epinephrine HCL w/w 0.01%

    Lidocaine HCl 5% w/w

    Purpose

    Vasoconstrictor

    Local Anesthetic

  • Uses:

    Temporarily relieves local discomfort or pain or burning associated with anorectal disorders.

  • Warnings:

    ​External use only

    Allergy alert: ​certain persons can develop allergic reactions to the ingredients in this product.

    Do not use:

    this product in the rectum by using fingers or any mechnical device or applicator.

    When using this product

    do not use more than directed.

    Stop use and ask a doctor

    if pain worsens or does notimprove in 7 days

    • if redness, irritation, swelling, pain or other symptoms develop or increase
    • if bleeding occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • adults: clean the affected area with mild soap and warm water and rinse thoroughly
    • dry gently
    • apply 1-2 g. externally to the affected area up to 4 times daily
    • children under 12 years: ask a doctor.
  • Other information:

    Store in a cool dark place

  • Inactive ingredients:

    Aqua (DI water), chlorobutanol, methylcellulose, sodium EDTA, sodium metabisulfite

  • Questions?

    Call Toll Free 888-452-4946

  • Package Labeling:

    Outer

  • INGREDIENTS AND APPEARANCE
    NUMQUICK TOPICAL ANALGESIC 
    epinephrine hydrochloride, lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67194-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE0.1 mg  in 1 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CHLOROBUTANOL (UNII: HM4YQM8WRC)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67194-005-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/20/2016
    Labeler - Unit Dose, Ltd. (119080393)
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