7 SELECT HEMORRHOIDAL ORIGINAL STRENGTH- mineral oil, petrolatum, and phenylephrine hcl ointment

7 Select Hemorrhoidal Original Strength by

Drug Labeling and Warnings

7 Select Hemorrhoidal Original Strength by is a Otc medication manufactured, distributed, or labeled by 7-ELEVEN, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                   Purpose

Mineral oil 14%......................................................Protectant

Petrolatum 74.9%..................................................Protectant

Phenylephrine HCl 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 of anorectal discomforts
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

WARNINGS

Warnings

For external and/or intrarectal use only

ASK DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

WHEN USING

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

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

INDICATIONS & USAGE

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, remove foil seal
• apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

STORAGE AND HANDLING

Other information

• store at 20-25°C (68-77°F)
• lot no. & exp. date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients 

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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY 7-ELEVEN, INC.

Irving, TX 75063

WWW.7-ELEVEN.COM

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

7 SELECT HEMORRHOIDAL ORIGINAL STRENGTH 
mineral oil, petrolatum, and phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10202-526
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
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)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10202-526-20	1 in 1 BOX	12/07/2016
1		20 g in 1 TUBE, WITH APPLICATOR; 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	12/07/2016

Labeler - 7-ELEVEN, INC. (007347602)