Hemorrhoidal Ointment

Hemorrhoidal Ointment
SPL v4
SPL
SPL Set ID a5b5e0a9-eee9-2a1e-e053-2a95a90a464e
Route
TOPICAL
Published
Effective Date 2020-05-15
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
Stearyl Alcohol Benzoic Acid Cetyl Alcohol Laureth-23 Methylparaben Yellow Wax Glycerin Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-14

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 intrarectal 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.

Packaging

Directions
  • Children under 12 years of age; ask 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
  • Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
  • For intrarectal use: remove protective cover from applicator and attach to tube. Lubricate applicator well then gently insert applicator into the rectum. Thoroughly clean applicator and replace protective cover after each use.
  • Regular use provides continual therapy for relief of symptoms

  • also apply ointment to external area.
Distributed By:

Distributed by RUGBY® LABORATORIES

17177 N. Laurel Park Drive, Suite 233

Livonia, MI. 48152

www.rugbylaboratories.com

Made in China

This Product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Preparation H® Hemorrhoidal Ointment.

Active Ingredient

Phenylephrine HCI 0.25%

Other Information
  • Store at room temperature 20º-25ºC (68º-77ºF)
Inactive Ingredients

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

Questions Or Comments?

1-800-645-2158

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 intrarectal 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.

Packaging

Directions
  • Children under 12 years of age; ask 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
  • Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
  • For intrarectal use: remove protective cover from applicator and attach to tube. Lubricate applicator well then gently insert applicator into the rectum. Thoroughly clean applicator and replace protective cover after each use.
  • Regular use provides continual therapy for relief of symptoms

  • also apply ointment to external area.
Distributed By: (Distributed by:)

Distributed by RUGBY® LABORATORIES

17177 N. Laurel Park Drive, Suite 233

Livonia, MI. 48152

www.rugbylaboratories.com

Made in China

This Product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Preparation H® Hemorrhoidal Ointment.

Active Ingredient

Phenylephrine HCI 0.25%

Other Information
  • Store at room temperature 20º-25ºC (68º-77ºF)
Inactive Ingredients

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

Questions Or Comments? (Questions or Comments?)

1-800-645-2158

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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