Drug Facts

Drug Facts

SPL v15

SPL

SPL Set ID 507c08ab-a98b-33fe-e2ac-eb9b9a810d5a

Route

TOPICAL

Published

Effective Date 2021-03-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Phenylephrine (2.5 mg) Mineral Oil (140 mg) Petrolatum (749 mg)

Inactive Ingredients

Benzoic Acid Butylated Hydroxyanisole Corn Oil Glycerin Lanolin Lanolin Alcohols Methylparaben Paraffin Propylparaben Water Thyme White Wax Tocopherol

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Active Since 2004-03-01

Description

Mineral oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%

Purpose

Protectant Protectant Vasoconstrictor

Medication Information

Purpose

Protectant Protectant Vasoconstrictor

Description

Mineral oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%

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

Purposes

Protectant

Vasoconstrictor

Warnings

For external and/or intrarectal use only

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)

Active Ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

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.

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor.

Principal Display Panel 57

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)

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.

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

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 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 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)

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug for high blood pressure or depression.

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)

Structured Label Content

Uses (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

Purposes (PURPOSES)

Protectant

Vasoconstrictor

Warnings (WARNINGS)

For external and/or intrarectal use only

Directions (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 (OTHER INFORMATION)

store at 20-25°C (68-77°F)

Active Ingredients (ACTIVE INGREDIENTS)

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Inactive Ingredients (INACTIVE INGREDIENTS)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

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

When Using This Product (When using this product)

do not exceed the recommended daily dosage unless directed by a doctor.

Principal Display Panel 57 (PRINCIPAL DISPLAY PANEL - 57)

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)

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (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

Principal Display Panel 28 G Tube Label (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 57 G Tube Label (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 28 G Tube Carton (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)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

presently taking a prescription drug for high blood pressure or depression.

Principal Display Panel 28 G Tube Label Paa119867 (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 (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)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "PURPOSES": "Protectant Protectant Vasoconstrictor", "WARNINGS": "For external and/or intrarectal use only", "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)", "ACTIVE INGREDIENTS": "Mineral oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%", "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.", "When using this product": "do not exceed the recommended daily dosage unless directed by a doctor.", "PRINCIPAL DISPLAY PANEL - 57": "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)", "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.", "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", "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 - 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 - 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)", "Ask a doctor or pharmacist before use if you are": "presently taking a prescription drug for high blood pressure or depression.", "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.780333 · Updated: 2026-03-14T23:02:34.788055