SPL v3
SPL
SPL Set ID 038a2cf5-1b72-227b-e063-6394a90a84ad
Route
RECTAL
Published
Effective Date 2023-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (2.5 mg) Petrolatum (749 mg) Mineral Oil (140 mg)
Inactive Ingredients
Paraffin Lanolin Thyme Benzoic Acid Butylated Hydroxyanisole Glycerin Lanolin Alcohols Corn Oil White Wax Tocopherol Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-22

Description

Active Ingredients Mineral oil 14% Petrolatum 74.9% Phenylephrine Hydrochloride 0.25%


Medication Information

Description

Active Ingredients Mineral oil 14% Petrolatum 74.9% Phenylephrine Hydrochloride 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

Section 55105-1

Active Ingredients Purpose

Mineral oil 14% ..................................................................... Protectant

Petrolatum 74.9%................................................................. Protectant

Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor

Section 60561-8

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.

Warnings:

Warnings: For external and/or intrarectal use only

Drug Facts

Active Ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine Hydrochloride 0.25%

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 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.

Other Information:

Store at 15°C - 30°C (59°F - 86°F).

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

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.

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).

If Pregnant Or Breast Feeding,

If pregnant or breast-feeding, ask a health professional before use.

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

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Tamper Evident Do Not Use If Seal On Tube Is Punctured Or Missing

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


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)

Section 55105-1 (55105-1)

Active Ingredients Purpose

Mineral oil 14% ..................................................................... Protectant

Petrolatum 74.9%................................................................. Protectant

Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor

Section 60561-8 (60561-8)

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.

Warnings:

Warnings: For external and/or intrarectal use only

Drug Facts

Active Ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine Hydrochloride 0.25%

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 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.

Other Information: (Other information:)

Store at 15°C - 30°C (59°F - 86°F).

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

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:)

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.

Keep Out of Reach of Children (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).

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

If pregnant or breast-feeding, ask a health professional before use.

Ask A Doctor Before Use If You Have: (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 (Ask a doctor or pharmacist before use)

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Tamper Evident Do Not Use If Seal On Tube Is Punctured Or Missing (TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING)

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


Advanced Ingredient Data


Raw Label Data

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