ACTIVE INGREDIENTS

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

PURPOSES

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

PREPARATION H
mineral oil, petrolatum, phenylephrine hcl ointment

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg in 1 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	140 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	749 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0573-2871-10	1 in 1 CARTON	03/01/2004
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0573-2871-20	1 in 1 CARTON	03/01/2004
2		57 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:0573-2871-04	2 in 1 PACKAGE	03/01/2004
3		1 in 1 CARTON
3		57 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:0573-2871-91	1 in 1 CARTON	03/01/2018
4		28 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:0573-2871-92	1 in 1 CARTON	03/01/2018
5		57 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:0573-2871-93	1 in 1 CARTON	06/01/2019
6		28 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:0573-2871-94	1 in 1 CARTON	05/17/2020
7		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M015	03/01/2004

Labeler - Haleon US Holdings LLC (079944263)

Name	Address	ID/FEI	Business Operations
Establishment
Pf Soins De Santé Sri		203812479	analysis(0573-2871) , label(0573-2871) , manufacture(0573-2871) , pack(0573-2871)

Drug Facts

ACTIVE INGREDIENTS

PURPOSES

USES

WARNINGS

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

QUESTIONS OR COMMENTS?

PRINCIPAL DISPLAY PANEL - 28 g Tube Label

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PRINCIPAL DISPLAY PANEL - 28 g Tube Label - PAA119867

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton - PAA119868

PRINCIPAL DISPLAY PANEL - 57 g Tube Label

PRINCIPAL DISPLAY PANEL - 57g Tube Carton