PREPARATION H- mineral oil, petrolatum, phenylephrine hcl ointment 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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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 20-25°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
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)

Revised: 3/2021
Document Id: 605f22c5-4df2-4c11-9d75-780f9e3826a4
Set id: 507c08ab-a98b-33fe-e2ac-eb9b9a810d5a
Version: 11
Effective Time: 20210310
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC