MAJOR PREP HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hydrochloride ointment

Major Prep Hemorrhoidal by

Drug Labeling and Warnings

Major Prep Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. 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
• trouble urinating due to an enlarged prostate gland

ASK DOCTOR/PHARMACIST

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

WHEN USING

When using this product do not exceed the recommended daily dosage

STOP USE

Stop use and ask a doctor if

• bleeding occurs
• condition gets worse or does not get better within 7 days
• introduction of the applicator into the rectum causes additional pain

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a physician 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

• children under 12 years of age: ask a doctor
• 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
• when first opening tube, remove foil seal
• for intrarectal use: remove protective cover from applicator and attach to tube
• lubricate applicator well, then gently insert applicator into the rectum
• thoroughly clean applicator and replace protective cover after each use
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• also apply ointment to external area

STORAGE AND HANDLING

Other information store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT

Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

DOSAGE & ADMINISTRATION

Distributed By

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAJOR PREP HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6356
Route of Administration	RECTAL, 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
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	749 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
THYME OIL (UNII: 2UK410MY6B)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6356-02	1 in 1 CARTON	10/11/2016
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	06/03/2014

Labeler - Major Pharmaceuticals (191427277)