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
• difficulty in urination due to enlargement of the prostate gland

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

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 (1-800-222-1222).

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.
• 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
• Children under 12 years of age: ask a doctor

Other Information

• Store at room temperature 20°-25°C (68°-77°F)
• Do not use if tube seal is broken or missing

Questions? Call 1-888-296-9067

Inactive Ingredients

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

Other Information

Distributed By:

CVS Pharmacy Inc.

One CVS Drive

Woodsocket, RI 02895

CVS.com

1 800 SHOP CVS

Made in China

V36582

Packaging

INGREDIENTS AND APPEARANCE

HEMORRHOIDALOINTMENT 
mineral oil, petrolatum, phenylephrine hci ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
LAURETH-23 (UNII: N72LMW566G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-083-01	1 in 1 BOX	06/28/2021
1		28 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 Drug	M015	06/28/2021

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)