Preparation h ointment

Drug facts

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 20-25C (68-77F)

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.

Ingredients and appearance - Product information

Preparation h ointment- Mineral oil, petrolatum, phenylephrine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0573-2871
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 2.5 mgin 1 g
Mineral oil ( UNII: T5L8T28FGP)( Mineral oil - UNII: T5L8T28FGP ) 140 mgin 1 g
Petrolatum ( UNII: 4T6H12BN9U)( Petrolatum - UNII: 4T6H12BN9U ) 749 mgin 1 g

Inactive Ingredients

Ingredient Name Code
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

Color YELLOW (smooth yellow ointment)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part346 USA

Labeler - Wyeth Consumer Healthcare LLC( 828831730)

Establishment

Name ID/FEI Business Operations
Wyeth Consumer Healthcare LLC 828831730 ANALYSIS( 0573-2871), LABEL( 0573-2871), MANUFACTURE( 0573-2871), PACK( 0573-2871)

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 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 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 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)