HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment

HemorrhoidalOintment by

Drug Labeling and Warnings

HemorrhoidalOintment by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor

Active Ingredient

Mineral Oil 14%

Purpose

Protectant

Active Ingredient

Petrolatum 74.9%

Purpose

Protectant

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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For external and/or anorectal use only

Ask doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

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

Stop Use and Ask Doctor if

• Bleeding occurs
• Condition worsens or does not improve within 7 days
• Introduction of applicator into the rectum causes additional pain

If Pregnant or Breast-Feeding

Ask a doctor before use

Keep out of reach of children

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

Directions

Adults and children 12 years of age and older for topical use:

• Clean the affected area and pat or dab dry before applying ointment
• Apply to the affected area up to 4 times daily, especially after bowel movement
• Attach included applicator to tube
• Lubricate applicator tip and gently insert into rectum
• Thoroughly clean applicator after each use and replace cover

Children under 12 years of age: ask a doctor before use

Other Information

• Store at room temperature 20°-25°C (68°-77°F)
• Close cap tightly after use

Questions? Call 1-888-296-9067

Inactive Ingredients

Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol

Distributed By:

Trifecta Pharamceuticals USA, LLC.

101 NE Third Ave. Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Packaging

INGREDIENTS AND APPEARANCE

HEMORRHOIDALOINTMENT 
mineral oil, petrolatum, phenylephrine hci ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	14 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	74.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
WHITE WAX (UNII: 7G1J5DA97F)
THYME OIL (UNII: 2UK410MY6B)
LANOLIN (UNII: 7EV65EAW6H)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-020-02	1 in 1 BOX	05/04/2017
1		56 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	05/04/2017

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)