PREFERRED PLUS HEMORRHOID- glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride cream

Preferred Plus Hemorrhoid by

Drug Labeling and Warnings

Preferred Plus Hemorrhoid by is a Otc medication manufactured, distributed, or labeled by Kinray, Inc., PJ Noyes Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Glycerin 14.4%

Petrolatum 15%

Phenylephrine HCl 0.25%

Pramoxine HCl1 %

Purposes

Protectant

Protectant

Vasoconstrictor

Local anesthetic

Uses

• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue
• temporarily relieves burning
• aids in protecting irritated anorectal areas

Warnings

For external use only

Ask a doctor before use if you have

• heart disease
• high blood pressure
• diabetes
• thyroid disease
• trouble urinating due to an enlarged 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 this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• bleeding occur
• condition gets worse or does not Improve within 7 days

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 and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying gel
• when first opening the tube, puncture foil seal with top end of cap
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• Children under 12 years of age: ask a doctor

Other information

• store at 20°-25°C (68°-77°F)
• for lot number and expiration date, see crimp of tube or see box

Inactive ingredients

• cetearyl alcohol, cetyl alcohol, monosterate, mineral oil, peg 40 castor oil, propylene glycol, purified water, stearyl alcohol, tocopheryl acetate (Vitamin E)

Principal Display Panel - 1 oz Carton Label

TAMPER-EVIDENT: Do not use if printed "safety sealed" overwrap is broken or missing.

NDC: 61715-092-01

Preferred Plus Pharmacy®

HEMORRHOIDAL

CREAM Maximum Strength Pain Relief

*Compare to the active ingredients in PREPARATION H® Cooling Gel

Smooth Cream Formula

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

SATISFACTION GUARANTEED

Preferred Plus Pharmacy®

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

PREFERRED PLUS HEMORRHOID 
glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-092
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	144 mg  in 1 L
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	150 mg  in 1 L
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	2.5 mg  in 1 L
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg  in 1 L

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Mineral Oil (UNII: T5L8T28FGP)
Peg-40 Castor Oil (UNII: 4ERD2076EF)
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
.ALPHA.-Tocopherol Acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-092-01	1 in 1 CARTON	03/28/2014
1		0.028 L 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	03/28/2014

Labeler - Kinray, Inc. (012574513)

Establishment
Name	Address	ID/FEI	Business Operations
PJ Noyes Company		018927392	MANUFACTURE(61715-092)