Label: LIDOCAINE 5% TOPICAL ANORECTAL CREAM cream

  • NDC Code(s): 73715-002-01
  • Packager: Mohnark Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 23, 2024

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  • Active Ingredients

    Lidocaine 5% w/w

  • Purpose

    Local Anesthetic

    Uses

    helps relieves pain, itching and burning associated with hemorrhoids and other anorectal disorders

  • Warnings

    For external use only

  • When using this product

    • avoid contact with eyes
    • do not exceed recommended dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • Stop use and ask doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs
    • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
    • symptoms clear up and return in a few days
  • Keep out of reach of children

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

  • Directions

    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
    • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
    • Children under 12 years of age: consult a doctor.
  • Other information

    • Store at USP controlled room temperature 20-25 oC (68-77 oF).
  • Inactive ingredients

    benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.

  • Dosage

    50 milligrams/gram per application

  • Usage

    • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
    • Children under 2 years of age: consult a doctor
  • Package Label

    5% Lidocaine cream

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 5% TOPICAL ANORECTAL CREAM 
    lidocaine 5% topical anorectal cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73715-002
    Route of AdministrationRECTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 2 g  in 100 g
    WATER (UNII: 059QF0KO0R) 80 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73715-002-0130 g in 1 TUBE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01506/15/2020
    Labeler - Mohnark Pharmaceuticals Inc. (117013830)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mohnark Pharmaceuticals Inc.117013830manufacture(73715-002)
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