Label: HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment

  • NDC Code(s): 69396-020-01, 69396-020-02, 69396-020-33, 69396-020-44
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 9, 2025

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  • Drug Facts

  • Active Ingredient

    Phenylephrine HCI 0.25%

  • Purpose

    Vasoconstrictor

  • Active Ingredient

    Mineral Oil 14%

  • Purpose

    Protectant

  • Active Ingredient

    Petrolatum 74.9%

  • Purpose

    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
    • Temporarily profects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • Warnings

    For external and/or anorectal use only

    Ask doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    Ask doctor before use if you are presently taking a prescription drug for high blood pressure

  • Stop Use and Ask Doctor if

    • Bleeding occurs
    • Condition worsens or does not improve within 7 days
    • Introduction of applicator into the rectum causes additional pain
  • If Pregnant or Breast-Feeding

    Ask a doctor before use

  • Keep out of reach of children

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

  • Directions

    Adults and children 12 years of age and older for topical use:

    • Clean the affected area and pat or dab dry before applying ointment
    • Apply to the affected area up to 4 times daily, especially after bowel movement
    • Attach included applicator to tube
    • Lubricate applicator tip and gently insert into rectum
    • Thoroughly clean applicator after each use and replace cover

    Children under 12 years of age: ask a doctor before use

  • Other Information

    • Store at room temperature 20°-25°C (68°-77°F)
    • Close cap tightly after use

    Questions? Call 1-888-296-9067

  • Inactive Ingredients

    Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol

  • Distributed By:

    Trifecta Pharamceuticals USA, LLC.®

    101 NE Third Ave. Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

  • PRINCIPAL DISPLAY PANEL

    4042 HEMORRHOIDAL OINTMENT 2OZ UPC 053025 CDER

  • PACKAGE LABEL

    404203-FBA GLOBE HEMORRHOIDAL OINTENT 2OZ 3PK_BOX 060525 CDER

  • PRINCIPAL DISPLAY PANEL

    404204-FBA GLOBE HEMORRHOIDAL OINTMENT 2OZ 4PK_BOX 060525 CDER

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDALOINTMENT 
    mineral oil, petrolatum, phenylephrine hci ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-020
    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
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM74.9 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BEESWAX (UNII: 2ZA36H0S2V)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    LAURETH-23 (UNII: N72LMW566G)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-020-021 in 1 BOX05/04/2017
    156 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-020-011 in 1 BOX09/14/2020
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69396-020-333 in 1 BOX03/12/2024
    356 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:69396-020-444 in 1 BOX03/12/2024
    456 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01505/04/2017
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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