Label: DRS PHARMACY HEMORRHOIDAL- phenylephrine hcl ointment

  • NDC Code(s): 80489-956-01
  • Packager: OL PHARMA TECH, LLC Drs PHARMACY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 16, 2024

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

  • ACTIVE INGREDIENTS

    1. Phenylephrine HCI, 0.25%
    2. Petrolatum 74.9 %
    3. mineral oil 14 %
  • PURPOSE

    • Vasoconstrictor
    • protectant
  • USES

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily shrinks hemorrhoidal tissue and relieves burning
    • temporarily provides a coating for relief of anorectal discomforts
    • aids in protecting irritated anorectal areas
    • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • WARNINGS

    For external use only and / or intrarectal use only

  • 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 a doctor or pharmacist before use if you are

    presently taking a prescription drug for high blood pressure or depression

  • WHEN USING THIS PRODUCT

    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • STOP USING AND ASK YOUR DOCTOR IF

    • bleeding occurs
    • condition worsens or does not improve within 7 days
  • IF PREGNENT OR BREAST-FEEDING

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying gel.
    • when first opening the tube, puncture foil seal with top end of cap
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • children under 12 years of age: ask a doctor
  • OTHER INFORMATION

    store at 20-25°C (68-77°F)

  • INACTIVE INGREDIENTS

    methylparaben, propylparaben, purified water, benzoic acid, butylated hydroxyanisole, corn oil, glycerine, lanolin, lanolin alcohols, mineral oil, paraffin, tocopherol, white wax

  • QUESTIONS

    www.drspharmacyusa.com

  • PRINCIPAL DISPLAY PANEL

    hemorrhoidal ointment

  • INGREDIENTS AND APPEARANCE
    DRS PHARMACY HEMORRHOIDAL 
    phenylephrine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-956
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    THYME (UNII: CW657OBU4N)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    WATER (UNII: 059QF0KO0R)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80489-956-011 in 1 CARTON11/01/2021
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01511/01/2021
    Labeler - OL PHARMA TECH, LLC Drs PHARMACY (021170377)
    Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377)
    Establishment
    NameAddressID/FEIBusiness Operations
    OL PHARMA TECH, LLC Drs PHARMACY021170377manufacture(80489-956)