Label: HEALMUSZ HEMORRHOID FISSURE- lidocaine 4% phenylephrine hcl 0.25% ointment

  • NDC Code(s): 84010-001-01
  • Packager: Jiangxi Hemei Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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  • Active Ingredient

    Lidocaine 4%

    Phenylephrine HCl 0.25%

  • Purpose

    Analgesic (pain relief) Vasoconstrictor

  • Use

    For external use only including the skin of the anal canal

  • Warnings

    When using this product do not exceed recommended daily dosage unless directed by a doctor, when using finger cots or an applicator, apply externally or the skin of the anal canal only.

  • Do not use

    Do not put this product into the rectum.

  • When Using

    When using this product do not exceed recommended daily dosage unless directed by a doctor, when using finger cots or an applicator, apply externally or the skin of the anal canal only.

  • Stop Use

    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, or presently taking a prescription for high blood pressure or depression.

  • Ask Doctor

    Stop use and ask a doctor if condition worsens or does not improve within seven days, bleeding occurs, an allergic reaction develops, thesymptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

  • Keep Oot Of Reach Of Children

    If swallowed, seek medical help or contact a Poison Control Center

  • Directions

    Adults: apply to 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.

  • Other information

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

  • Inactive ingredients

    Borneol，Carbomer Homopolymer，Chlorhexidine Acetate Glycerin，Thymol

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    HEALMUSZ HEMORRHOID FISSURE 
    lidocaine 4% phenylephrine hcl 0.25% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84010-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    BORNEOL (UNII: M89NIB437X)  
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84010-001-0142.5 g in 1 TUBE; Type 0: Not a Combination Product01/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/17/2024
    Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangxi Hemei Pharmaceutical Co., Ltd724892056label(84010-001) , manufacture(84010-001)
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