0.25 % Phenylephrine Hcl Hemorrhoidal Ointment

0.25 % Phenylephrine Hcl Hemorrhoidal Ointment
SPL v1
SPL
SPL Set ID 90844919-f16a-4390-9dca-b0405b501445
Route
TOPICAL
Published
Effective Date 2026-01-19
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
Yellow Wax Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-19

Description

Mineral Oil 14%  Petrolatum 74.9%  Phenylephrine HCl 0.25%

Purpose

Protectant Protectant Vasoconstrictor


Medication Information

Purpose

Protectant

Protectant

Vasoconstrictor

Description

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 42229-5

FAST RELIEF OINTMENT

✓ Relieves burning

✓ Soothes pain

✓ itching & swelling

Mfd for and Distributed by:

Universal Distribution Center LLC

330 Applegarth Road,

Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist 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

Stop use and ask a 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 healthcare professional before use

Packaging

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 secured on tube • 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 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 • children under 12 years of age: ask a doctor.

Drug Facts

Active Ingredient

Mineral Oil 14% 

Petrolatum 74.9% 

Phenylephrine HCl 0.25%

Other Information

​• store at 20°–25°C (68°–77°F) • do not use if tube seal under cap is broken

Inactive Ingredients

beeswax, ceteareth-20, cetostearyl alcohol, glycerin


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 42229-5 (42229-5)

FAST RELIEF OINTMENT

✓ Relieves burning

✓ Soothes pain

✓ itching & swelling

Mfd for and Distributed by:

Universal Distribution Center LLC

330 Applegarth Road,

Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Protectant

Protectant

Vasoconstrictor

Warnings

For external use only.

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist 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

Stop use and ask a 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 healthcare professional before use

Packaging

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 secured on tube • 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 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 • children under 12 years of age: ask a doctor.

Drug Facts

Active Ingredient (Active ingredient)

Mineral Oil 14% 

Petrolatum 74.9% 

Phenylephrine HCl 0.25%

Other Information (Other information)

​• store at 20°–25°C (68°–77°F) • do not use if tube seal under cap is broken

Inactive Ingredients (Inactive ingredients)

beeswax, ceteareth-20, cetostearyl alcohol, glycerin


Advanced Ingredient Data


Raw Label Data

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