Topco Associates Llc. Hemorrhoidal Ointment Drug Facts

Topco Associates Llc. Hemorrhoidal Ointment Drug Facts
SPL v1
SPL
SPL Set ID 51521353-a859-4d6b-84eb-6523e780989c
Route
RECTAL
Published
Effective Date 2013-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (140.000 mg) Petrolatum (749.000 mg) Phenylephrine (2.500 mg)
Inactive Ingredients
Butylated Hydroxytoluene Cod Liver Oil Glycerin Lanolin Methylparaben Paraffin Propylparaben Water Sodium Benzoate Squalane Thyme Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-07-22

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

Purposes

Protectant

Protectant

Vasoconstrictor

Warnings

For external and/or intrarectal use only

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 20-25oC (68-77oF)
Active Ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Inactive Ingredients

bees wax, butylated hydroxytoluene, cod liver oil, glycerin, lanolin, methylparaben, paraffin wax, propylparaben, purified water, sodium benzoate, squalane, thyme oil, tocopherol acetate

Questions Or Comments?

1-888-423-0139

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 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 the prostate gland
Package/label Principal Display Panel

MEDICATED

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

COMPARE TO PREPARATION H® HEMORRHOIDAL OINTMENT active ingredients

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

Purposes

Protectant

Protectant

Vasoconstrictor

Warnings

For external and/or intrarectal use only

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 20-25oC (68-77oF)
Active Ingredients (Active ingredients)

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Inactive Ingredients (Inactive ingredients)

bees wax, butylated hydroxytoluene, cod liver oil, glycerin, lanolin, methylparaben, paraffin wax, propylparaben, purified water, sodium benzoate, squalane, thyme oil, tocopherol acetate

Questions Or Comments? (Questions or comments?)

1-888-423-0139

When Using This Product (When using this product)

do not exceed the recommended daily dosage unless directed by a doctor

Stop Use and Ask A Doctor If (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, (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 the prostate gland
Package/label Principal Display Panel (Package/Label Principal Display Panel)

MEDICATED

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

COMPARE TO PREPARATION H® HEMORRHOIDAL OINTMENT active ingredients

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.


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