PREFERRED PLUS HEMORRHOIDAL- phenylephrine hydrochloride, witch hazel cream

Preferred Plus Hemorrhoidal by

Drug Labeling and Warnings

Preferred Plus Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Kinray Inc., Natural Essentials. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Phenylephrine hydrochloride 0.25%

Witch hazel 50.0%

PURPOSE

Vasoconstrictor

Astringent

Uses

• temporarily relieves irritation and burning
• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue
• 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
• 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

• aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, 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: 61715-093-01

Preferred Plus Pharmacy®

HEMORRHOIDAL

Cooling Gel with aloe

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

Fast Cooling Relief

• Clean, Non-Greasy Formula with No Unpleasant Scent
• Prompt Cooling Relief from Painful Burning and Itching
• Shrinks Swollen Hemorrhoidal Tissue
• Relieves External Discomfort

SATISFACTION GUARANTEED

Preferred Plus Pharmacy®

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

PREFERRED PLUS HEMORRHOIDAL 
phenylephrine hydrochloride, witch hazel cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-093
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	phenylephrine hydrochloride	2.5 mg  in 1 L
witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34)	witch hazel	500 mg  in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
edetate disodium (UNII: 7FLD91C86K)
hydroxyethyl cellulose (100 mpa.s at 2%) (UNII: R33S7TK2EP)
methylparaben (UNII: A2I8C7HI9T)
polysorbate 80 (UNII: 6OZP39ZG8H)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium citrate (UNII: 1Q73Q2JULR)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-093-01	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
Natural Essentials		947484713	MANUFACTURE(61715-093)