Label: PREPARATION H- mineral oil, petrolatum, phenylephrine hcl ointment

  • NDC Code(s): 0573-2871-04, 0573-2871-10, 0573-2871-20, 0573-2871-91, view more
    0573-2871-92, 0573-2871-93, 0573-2871-94
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 17, 2023

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

  • ACTIVE INGREDIENTS

    Mineral oil 14%

    Petrolatum 74.9%

    Phenylephrine HCl 0.25%

  • PURPOSES

    Protectant

    Protectant

    Vasoconstrictor

  • 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 protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • WARNINGS

    For external 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.

    Stop use and ask a 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 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 ointment.
    • when first opening the tube, puncture foil seal with top end of cap
    • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • intrarectal use:
      • remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum
      • thoroughly cleanse applicator after each use and replace cover
    • also apply ointment to external area
    • regular use provides continual therapy for relief of symptoms
    • children under 12 years of age: ask a doctor
  • OTHER INFORMATION

    store at 20-25°C (68-77°F)

  • INACTIVE INGREDIENTS

    benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax

  • QUESTIONS OR COMMENTS?

    Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374.

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Label

    THIS PACKAGE CONTAINS AN OUTER CARTON. DO NOT BUY IF OUTER CARTON IS MISSING.

    PREPARATION H ®
    HEMORRHOIDAL OINTMENT

    Prevents Further
    Irritation

    • Prompt, Soothing Relief from Painful
      Burning, Itching and Discomfort
    • Shrinks Swollen Hemorrhoidal Tissue
    • Protects Irritated Tissue
    • Relieves Internal and External Discomfort

    NET WT 1 OZ (28 g)

    Principal Display Panel - 28 g Tube Label
  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    PREPARATION H ®
    HEMORRHOIDAL OINTMENT

    Prevents Further
    Irritation

    • Prompt, Soothing Relief from
      Painful Burning, Itching and Discomfort
    • Shrinks Swollen Hemorrhoidal Tissue
    • Protects Irritated Tissue
    • Relieves Internal and External Discomfort

    NET WT 1 OZ (28 g)

    Principal Display Panel - 28 g Tube Carton
  • PRINCIPAL DISPLAY PANEL - 28 g Tube Label - PAA119867

    PREPARATION H ®

    HEMORRHOIDAL
    OINTMENT

    Prevents Further
    Irritation

    • Prompt, Soothing Relief
      from Painful Burning,
      Itching, & Discomfort
    • Shrinks Swollen
      Hemorrhoidal Tissue
    • Protects Irritated Tissue
    • Relieves Internal &
      External Discomfort

    NET WT 1.0 OZ (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Label - PAA119867
  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton - PAA119868

    PREPARATION H ®

    HEMORRHOIDAL
    OINTMENT

    Prevents Further
    Irritation

    New Look,
    SAME SIZE!

    • Prompt, Soothing Relief from Painful
      Burning, Itching, & Discomfort
    • Shrinks Swollen Hemorrhoidal Tissue
    • Protects Irritated Tissue
    • Relieves Internal & External Discomfort

    1 TUBE | NET WT 1 OZ (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton - PAA119868
  • PRINCIPAL DISPLAY PANEL - 57 g Tube Label

    PREPARATION H ®

    HEMORRHOIDAL
    OINTMENT

    Prevents Further
    Irritation

    • Prompt, Soothing Relief from
      Painful Burning, Itching,
      & Discomfort
    • Shrinks Swollen
      Hemorrhoidal Tissue
    • Protects Irritated Tissue
    • Relieves Internal &
      External Discomfort

    NET WT 2.0 OZ (57 g)

    PRINCIPAL DISPLAY PANEL - 57 g Tube Label
  • PRINCIPAL DISPLAY PANEL - 57g Tube Carton

    PREPARATION H ®

    HEMORRHOIDAL
    OINTMENT

    Prevents Further
    Irritation

    • Prompt, Soothing Relief from Painful
      Burning, Itching, & Discomfort
    • Shrinks Swollen Hemorrhoidal Tissue
    • Protects Irritated Tissue
    • Relieves Internal & External Discomfort

    1 TUBE | NET WT 2 OZ (57 g)

    PRINCIPAL DISPLAY PANEL - 57 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    PREPARATION H 
    mineral oil, petrolatum, phenylephrine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2871
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    THYME (UNII: CW657OBU4N)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    Coloryellow (smooth yellow ointment) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2871-101 in 1 CARTON03/01/2004
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0573-2871-201 in 1 CARTON03/01/2004
    257 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0573-2871-042 in 1 PACKAGE03/01/2004
    31 in 1 CARTON
    357 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0573-2871-911 in 1 CARTON03/01/2018
    428 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:0573-2871-921 in 1 CARTON03/01/2018
    557 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:0573-2871-931 in 1 CARTON06/01/2019
    628 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:0573-2871-941 in 1 CARTON05/17/2020
    757 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01503/01/2004
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pf Soins De Santé Sri203812479analysis(0573-2871) , label(0573-2871) , manufacture(0573-2871) , pack(0573-2871)