Label: HEMORRHOIDALCREAMPROCURE- phenylephrine hcl, petrolatum, mineral oil cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Mineral Oil (14% w/w)............................................. Skin Protectant

    Petrolatum (74.9% w/w)........................................... Skin Protectant


    Phenylephrine HCl (0.25% w/w).................. Vasoconstrictor

  • INDICATIONS & USAGE

    Uses

    • Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
    • Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
  • WARNINGS

    Warnings

    For external 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 into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days
    • an allergic reaction develops
    • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

    If pregnant 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
    • To use applicator, attach it to the tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly
    • Apply externally to the affected area up to 4 times daily, especially at night, when waking up and after each bowel movement
    • Children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    store at 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Alpha Tocopherol (Vitamin E), Benzoic Acid, Butylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, PEG-40 Hydrogenated Castor Oil, PEG-100 Stearate, Propylene Glycol, Thymus Vulgaris (Thyme) Flower/Leaf Oil, White Wax

  • PRINCIPAL DISPLAY PANEL

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDALCREAMPROCURE 
    phenylephrine hcl, petrolatum, mineral oil cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM74.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55681-410-5556.6 g in 1 TUBE; Type 0: Not a Combination Product10/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01510/05/2022
    Labeler - TWIN MED, LLC (009579330)
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