Hemorrhoidal Ointment

SPL v2

SPL

SPL Set ID 44cfb486-a5fd-10ee-e054-00144ff8d46c

Route

TOPICAL

Published

Effective Date 2016-12-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (0.25 g) Mineral Oil (14 g) Petrolatum (74.9 g)

Inactive Ingredients

Methylparaben White Wax Paraffin Thyme Oil Lanolin Glycerin Propylparaben

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-12-29

Description

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor

Medication Information

Purpose

Vasoconstrictor

Description

Phenylephrine HCI 0.25%

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

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

Packaging

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

Distributed By:

Trifecta Pharmaceuticals USA, LLC

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Active Ingredient

Phenylephrine HCI 0.25%

Other Information

Store at room temperature 20º-25ºC (68º-77ºF)
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

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

Structured Label Content

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

Purpose

Vasoconstrictor

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

Packaging

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

Distributed By: (Distributed by:)

Trifecta Pharmaceuticals USA, LLC

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Active Ingredient

Phenylephrine HCI 0.25%

Other Information

Store at room temperature 20º-25ºC (68º-77ºF)
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

Stop Use and Ask Doctor If (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 (If Pregnant or breast-feeding)

Ask a doctor 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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Vasoconstrictor", "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", "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", "Distributed by:": "Trifecta Pharmaceuticals USA, LLC 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com", "Active Ingredient": "Phenylephrine HCI 0.25%", "Other Information": "Store at room temperature 20º-25ºC (68º-77ºF) 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", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.642406 · Updated: 2026-03-14T22:54:54.026912