Label: FARGELIN HEMORRHOIDAL- calamine, petrolatum and phenylephrine hydrochloride ointment

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 22, 2022

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  • ACTIVE INGREDIENT

    Active ingredients
    Calamine 10.5%
    Petrolatum 79.25%
    Phenylephrine hydrochloride 0.25%

  • PURPOSE

    Purpose
    Hemorrhoidal (anorectal) astringent/protectant
    Hemorrhoidal (anorectal) protectant
    Hemorrhoidal (anorectal) vasoconstrictor

  • INDICATIONS & USAGE

    Uses
    temporarily helps relieve:

         anorectal burning, itching, and discomfort associated with hemorrhoids
    temporarily:

         reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders

         shrinks hemorrhoidal tissue

         protects inflamed perianal skin and irritated areas

  • WARNINGS

    Warnings
    For rectal use only

  • ASK DOCTOR

    Ask a doctor before use if you have
    heart disease
    high blood pressure
    thyroid disease
    diabetes
    difficulty in urination due to enlargement of the prostate gland

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug for high blood pressure or depression

  • WHEN USING

    When using this product
    in case of bleeding; consult a doctor promptly
    
do not exceed the recommended daily dosage unless directed by a doctor
    
do not use with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

  • STOP USE

    Stop use and ask a doctor if
    condition worsens
    symptoms do not improve within 7 days

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults: 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 a soft cloth before application of this product.
      • For external hemorrhoids, apply a small amount of ointment directly to the affected area up to 4 times daily.
      • FOR INTRARECTAL USE (internal hemorrhoids): Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Squeeze a small amount (2 g) of the ointment into the rectum. Remove and discard used applicator. Apply to the affected area up to 4 times daily.
    • children under 12 years of age: consult a doctor.
  • STORAGE AND HANDLING

    Other information
    keep container tightly closed

    store at room temperature 20 - 25 C (68 - 77 F)

    do not use if the physical properties of this product have changed

  • INACTIVE INGREDIENT

    Inactive ingredients Amber, callicarpa nudiflora leaf, corydalis yanhusuo tuber, lanolin, panax notoginseng root, pearl, sanguisorba officinalis root, scutellaria baicalensis root, sodium borate, and styphnolobium japonicum flower.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

  • PRINCIPAL DISPLAY PANEL

    FARGELIN HEMORRHOIDAL OINTMENT

    NDC 55614-610-01

    0.705 oz (20 g)
    box-02.jpg

  • INGREDIENTS AND APPEARANCE
    FARGELIN HEMORRHOIDAL 
    calamine, petrolatum and phenylephrine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-610
    Route of AdministrationTOPICAL, RECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.3 g  in 100 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.05 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM79.25 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMBER (UNII: 70J9Z0J26P)  
    CALLICARPA NUDIFLORA LEAF (UNII: IRA5LS3VXW)  
    CORYDALIS YANHUSUO TUBER (UNII: 0TUP42692Z)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55614-610-0120 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product11/27/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34611/27/2019
    Labeler - MADISON ONE ACME INC (096196758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-610)