Hemorrhoidal Pain Relief Ointment

Hemorrhoidal Pain Relief Ointment
SPL v1
SPL
SPL Set ID 374d89b6-9305-9adf-e063-6394a90adb32
Route
TOPICAL
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (749 mg) Mineral Oil (140 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Methylparaben Paraffin Water Thymus Vulgaris (thyme) Oil Lanolin Propylparaben Glycerin Benzoic Acid Butylated Hydroxytoluene Alpha-tocopherol Acetate Lanolin Alcohol White Wax Corn Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-11

Description

Active Ingredients: Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%


Medication Information

Description

Active Ingredients: Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCl 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
Section 51945-4

Warnings:

For external and/or intrarectal use only

Drug Facts

Active Ingredients:

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Important:

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

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.
  • When first opening the tube, puncture foil seal with top end of cap.
  • 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 the 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.
Drug Facts:

Purpose

Protectant

Protectant

Vasoconstrictor

Other Information:

Store at 15°C – 30°C (59°F – 86°F)

  • Children under 12 years of age: ask a doctor
Inactive Ingredients:

Benzoic acid, butylated hydroxytoluene, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, propylparaben, paraffin wax, purified water, thymus vulgaris oil, tocopherol, acetate, white wax

Questions Or Comments?

1 (877) 477-8633

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

When Using This Product:
  • Do not exceed the recommended daily dosage unless directed by a doctor
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 health professional 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)

Ask A Doctor Before Use If You Have:
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Difficulty in urination due to enlargement of prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are:

Presently taking a prescription drug for high blood pressure or depression


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
Section 51945-4 (51945-4)

Warnings:

For external and/or intrarectal use only

Drug Facts

Active Ingredients:

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Important:

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

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.
  • When first opening the tube, puncture foil seal with top end of cap.
  • 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 the 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.
Drug Facts:

Purpose

Protectant

Protectant

Vasoconstrictor

Other Information:

Store at 15°C – 30°C (59°F – 86°F)

  • Children under 12 years of age: ask a doctor
Inactive Ingredients: (Inactive ingredients:)

Benzoic acid, butylated hydroxytoluene, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, propylparaben, paraffin wax, purified water, thymus vulgaris oil, tocopherol, acetate, white wax

Questions Or Comments? (Questions or comments?)

1 (877) 477-8633

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

When Using This Product: (When using this product:)
  • Do not exceed the recommended daily dosage unless directed by a doctor
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 health professional 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. (1-800-222-1222)

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Difficulty in urination due to enlargement of prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are: (Ask a doctor or pharmacist before use if you are:)

Presently taking a prescription drug for high blood pressure or depression


Advanced Ingredient Data


Raw Label Data

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