WINCO HEMORRHOIDAL- mineral oil, petrolatum, and phenylephrine hydrochloride cream

Winco Hemorrhoidal by

Drug Labeling and Warnings

Winco Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Winco Foods, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each gram)                                                                       Purpose

Mineral oil 14%  ---------------------------------------------------------------------      Protectant

Petrolatum 74.9%-------------------------------------------------------------------       Protectant

Phenylephrine hydrochloride 0.25% -----------------------------------------------       Vasoconstrictor

PURPOSE

Uses

• Helps relieve the local itching and discomfort associated with hemorrhoids
• Temporarily shrinks hemorrhoidal tissue and relieves burning
• Temporarily provides a coating for relief or anorectal discomforts
• temporarily portects the inflamed, irritated anorectal surface to help make bowel movements less painful

WARNINGS

For External use only and/or intrarectal use only

Children under 12 years of age:ask a doctor

ASK DOCTOR

Ask a doctor before use if you have

heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating 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 depresion

WHEN USING

When using this product do not exceed the recommended daily dosage unless directly by a doctor

DO NOT USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of childern.

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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 tube, remove foil seal

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

STORAGE AND HANDLING

Other information:

• store between 20° yp 25°C (68° to 77°F)
• Lot No. & Exp. Date:see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

ethanol, glycerin, lanolin, methylparaben, polyborbate 80, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WINCO HEMORRHOIDAL 
mineral oil, petrolatum, and phenylephrine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-278
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
THYME OIL (UNII: 2UK410MY6B)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHITE WAX (UNII: 7G1J5DA97F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-278-57	1 in 1 CARTON	01/29/2015
1		57 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	01/29/2015

Labeler - Winco Foods, LLC (056098817)