PREPARATION H MAXIMUM STRENGTH- glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream

PREPARATION H by

Drug Labeling and Warnings

PREPARATION H by is a Otc medication manufactured, distributed, or labeled by Wyeth Consumer Healthcare LLC, PF Consumer Healthcare Canada ULC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
Glycerin 14.4%	Protectant
Phenylephrine HCl 0.25%	Vasoconstrictor
Pramoxine HCl 1%	Local anesthetic
White petrolatum 15%	Protectant

INDICATIONS & USAGE

Uses

• for temporary relief of pain, soreness and burning
• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue
• temporarily provides a coating for relief of anorectal discomforts
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

WARNINGS

Warnings

For external 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
• do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• bleeding occurs
• condition worsens or does not improve within 7 days
• an allergic reaction develops
• the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

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.

DOSAGE & ADMINISTRATION

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 cream.
• when first opening the tube, puncture foil seal with top end of cap
• apply externally or in the lower portion of the anal canal only
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
• thoroughly cleanse dispensing cap after each use and replace cover
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

QUESTIONS

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

PREPARATION H®

HEMORRHOIDAL
CREAM

Multi-Symptom
Pain Relief

WITH
ALOE

New Look,
SAME SIZE!

• Soothing Pain Relief from Burning,
  Itching, & Discomfort
• Shrinks Swollen Hemorrhoidal Tissue
• Protects Irritated Tissue
• Relieves External Discomfort
• Proprietary Blend with Vitamin E
  and Aloe

1 TUBE | NET WT 0.9 OZ (26 g)

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton

PREPARATION H®
HEMORRHOIDAL CREAM

Maximum Strength Pain Relief

Smooth Cream
Formula with Aloe

• Rapid, Soothing Pain Relief from Painful
  Burning, Itching and Discomfort
• Shrinks Swollen Hemorrhoidal Tissue
• Protects Irritated Tissue
• Relieves External Discomfort

NET WT. 1.8 OZ (51 g)

INGREDIENTS AND APPEARANCE

PREPARATION H   MAXIMUM STRENGTH
glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2868
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	144 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-23 (UNII: N72LMW566G)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2868-10	1 in 1 CARTON	07/01/2004
1		26 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0573-2868-20	1 in 1 CARTON	07/01/2004
2		51 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0573-2868-93	1 in 1 CARTON	01/01/2019
3		26 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	07/01/2004

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Establishment
Name	Address	ID/FEI	Business Operations
PF Consumer Healthcare Canada ULC		203812479	ANALYSIS(0573-2868) , LABEL(0573-2868) , MANUFACTURE(0573-2868) , PACK(0573-2868)