Hemorrhoidal Ointment

Hemorrhoidal Ointment
SPL v5
SPL
SPL Set ID 3803a61b-308a-14a9-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-09-01
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
Glycerin Lanolin Propylparaben Thyme Oil White Wax Paraffin Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-07-19

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 or depression

When using this product do not exceed the recommended daily dosage unless directed by a doctor

Packaging

Directions

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

Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe

  • gently dry by patting or blotting with a tissue or soft cloth before applying
  • when first opening tube, remove foil seal
  • for intrarectal use: remove protective cover from applicator into the rectum
  • 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
Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Active Ingredient

Phenylephrine HCI 0.25%

Other Information

Store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Beeswax, benzolc acid, Cetyl alcohol, Glycerol, Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, stearyl alcohol

Hemorrhoidal Ointment
  • Prevents Further Irritation
  • Prompt Soothing Relief from Painful Burning, Itching and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves Internal and External Discomfort
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 or depression

When using this product do not exceed the recommended daily dosage unless directed by a doctor

Packaging

Directions

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

Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe

  • gently dry by patting or blotting with a tissue or soft cloth before applying
  • when first opening tube, remove foil seal
  • for intrarectal use: remove protective cover from applicator into the rectum
  • 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
Distributed By: (Distributed by:)

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Active Ingredient

Phenylephrine HCI 0.25%

Other Information

Store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Beeswax, benzolc acid, Cetyl alcohol, Glycerol, Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, stearyl alcohol

Hemorrhoidal Ointment
  • Prevents Further Irritation
  • Prompt Soothing Relief from Painful Burning, Itching and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves Internal and External Discomfort
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

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