Label: ANORECTAL HEMORRHOIDAL CREAM WITH LIDOCAINE 5%- lidocaine 5% cream cream

  • NDC Code(s): 55629-019-04, 55629-019-05
  • Packager: ONE2ZEE LIMITED LIABILITY COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 25, 2024

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  • DRUG FACTS:

  • Active Ingredient:

    Lidocaine HCl 5.0%

  • Purpose

    • Anorectal (Hemorrhoidal) Cream
  • Uses:

    Helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.

  • Warnings:

    • For external use only. If condition worsens or does not improve within 7 days, consult a doctor.
  • When using this product,

    • Do not exceed the recommended daily dosage unless directed by a doctor.
    • In case of bleeding, consult a doctor promptly.
    • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
    • Keep out of reach of children.
    • If swallowed, get medical help or contact the Poison Control Center immediately.
    • If pregnant or breast feeding, ask a health professional before use.
  • Directions:

    Children under 12: Consult a doctor.

    Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product. Apply externally up to 6 times per day.

  • Keep out of reach of children.

  • Inactive Ingredients

    Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate

  • Other Information:

    Store at room temperature. Avoid direct sunlight. Do not use if tamper evident packaging has been breached or is missing. See bottom of this jar for lot number and expiry date.

    Distributed by: Wellspring Airmont, NY 10952 U.S.A.

  • Packaging label for the tube

    4oz tube4oz carton

    Package Label for the Jar

    5oz jar

  • INGREDIENTS AND APPEARANCE
    ANORECTAL HEMORRHOIDAL CREAM WITH LIDOCAINE 5% 
    lidocaine 5% cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55629-019-04113 g in 1 TUBE; Type 0: Not a Combination Product09/25/2024
    2NDC:55629-019-05142 g in 1 JAR; Type 0: Not a Combination Product09/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM09/25/2024
    Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
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