Label: LIDOCAINE cream

  • NDC Code(s): 83589-301-01, 83589-301-02, 83589-301-03
  • Packager: Nanjing Cuccess Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 26, 2024

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  • Active Ingredients

    Lidocaine 4% w/w

  • Purpose

    Topical anesthetic

  • Uses

    For the temporary relief of pain, itching and burning associated with hemorrhoids and other anorectal disorders.

  • Warnings

    For external 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 a doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs
    • symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
    • symptoms clear up and return within 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 eyternally to the attected area un to 6 times a day.
    • Children under 12 years of age: consult a doctor.
  • Other information

    Store at USP controlled room temperature 20-25℃ (68-77°F).

  • Inactive ingredient

    benzyl alcohol, carbomer homopolymer type C 980NF, cholesterol, isopropyl myristate, polysorbate 80, propylene glycol, purified water, soybean lecithin, tocopherol.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    labeling

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83589-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE1.2 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83589-301-011 in 1 BOX04/04/2024
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:83589-301-031 in 1 BOX04/04/2024
    2120 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:83589-301-021 in 1 BOX04/04/2024
    325 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01504/04/2024
    Labeler - Nanjing Cuccess Pharmaceutical Co., Ltd. (420793416)
    Registrant - Nanjing Cuccess Pharmaceutical Co., Ltd. (420793416)
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