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
  • 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 December 2, 2022

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  • 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 1-800-99PrepH or 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 - 57 g 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 FINALpart34603/01/2004
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Consumer Healthcare Canada ULC203812479ANALYSIS(0573-2871) , LABEL(0573-2871) , MANUFACTURE(0573-2871) , PACK(0573-2871)
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