Label: LIDOCAINE 4% TOPICAL ANESTHETIC CREAM- lidocaine 4% cream cream

  • NDC Code(s): 73715-001-01
  • 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 4% w/w

  • Purpose

    Topical Anesthetic

    Uses temporarily relieves pain and itching due to:

    • minor cuts
    • minor scrapes
      • sunburn
      • minor skin irritations
      • minor burns
      • insect bites
  • Warnings

    For external use only

  • When using this product

    • do not use in or near the eyes
    • do not use in large quantities, particularly over raw surfaces or blistered areas
  • Stop use and ask a doctor if

    • allergic reaction occurs
    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • redness, irritation, swelling, pain or other symptoms begin or increase
  • Keep out of reach of children

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

  • Directions

    • 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
  • Other information

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

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

  • Dosage

    40 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

    4% Lidocaine cream

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 4% TOPICAL ANESTHETIC CREAM 
    lidocaine 4% cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73715-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4.27 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 2 g  in 100 g
    WATER (UNII: 059QF0KO0R) 80.48 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73715-001-0130 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 DrugM01706/15/2020
    Labeler - Mohnark Pharmaceuticals Inc. (117013830)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mohnark Pharmaceuticals Inc.117013830manufacture(73715-001)
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