Label: HEMORRHOID OINTMENTS- lidocaine paste

  • NDC Code(s): 84023-401-01
  • Packager: Shenzhen Yangan Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 30, 2024

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  • SPL UNCLASSIFIED SECTION

    Hemorrhoid Ointment

  • ACTIVE INGREDIENT

    Lidocaine 5%

  • PURPOSE

    Topical Anesthetic

  • INDICATIONS & USAGE

    Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burnina, itching).
    Temporarily reduces the sweling associated with irritated hemorrhoidal tissue and other anorectal disorders.

  • WARNINGS

    For externaand/or intrarectal use only

  • WHEN USING

    Do not exceed recommended daily dosage unless directed by a doctor.

    Ask a doctor before use if you have:
    Allergies to any of the components of this product.
    Difficulty in urination due to enlargement of the prostate gland.
    Diabetes: Heart Disease : High Blood Pressure Thyroid Disease.
    Presently taking a prescription for high blood pressure or depression.

  • STOP USE

    Condition worsens or does not improve within seven (7) days.
    Bleeding occurs.
    Introduction of applicator into the rectum causes additional pain.

  • DO NOT USE

    lf pregnant or breast-feeding, ask a health care professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. lf swallowed, seek medical help or contact a Poison Contro Center right away.

  • DOSAGE & ADMINISTRATION

    Children under 12 years of age consult your pediatrician.
    Adults: apply to the affected area up to 3 times daily.
    Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.
    To use dispensing cap, attach it to tube, lubricate well. then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

  • STORAGE AND HANDLING

    Store at 59* to 77*F to avoid melting

  • INACTIVE INGREDIENT

    Aloe barbadebsis leaf juice (Aloe vera)
    Water
    Lecithin (Soybean)

    Carbomer
    Menthol
    Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HEMORRHOID OINTMENTS 
    lidocaine paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84023-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    MENTHOL (UNII: L7T10EIP3A)  
    ALOE (UNII: V5VD430YW9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84023-401-011 in 1 BOX01/30/2024
    160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/30/2024
    Labeler - Shenzhen Yangan Technology Co., Ltd. (419283765)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Yangan Technology Co., Ltd.419283765manufacture(84023-401)