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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 9, 2020

If you are a consumer or patient please visit this version.

  • 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)