hemorrhoidal ointment

hemorrhoidal ointment
SPL v10
SPL
SPL Set ID 4eb3c9ac-268a-5246-e054-00144ff88e88
Route
topical
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
mineral oil (14 g) petrolatum (74.9 g) phenylephrine (0.25 g)
Inactive Ingredients
cetyl alcohol beeswax propylparaben methylparaben glycerin benzoic acid laureth-23 stearyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-05-04

Purpose

Vasoconstrictor

Description

Phenylephrine HCI 0.25%


Medication Information

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

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
Purpose

Vasoconstrictor

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

Description

Phenylephrine HCI 0.25%

Section 51945-4

Package Label

Distributed By:

Trifecta Pharamceuticals USA, LLC.®

101 NE Third Ave. Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Active Ingredient

Phenylephrine HCI 0.25%

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

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

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
Purpose

Vasoconstrictor

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

Section 51945-4 (51945-4)

Package Label (PACKAGE LABEL)

Distributed By:

Trifecta Pharamceuticals USA, LLC.®

101 NE Third Ave. Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Active Ingredient

Phenylephrine HCI 0.25%

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


Raw Label Data

All Sections (JSON)