SPL v3
SPL
SPL Set ID 93482a9b-145b-42d4-96db-599c281a39f1
Route
TOPICAL
Published
Effective Date 2022-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (140 mg) Petrolatum (749 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Yellow Wax Benzoic Acid Cetyl Alcohol Glycerin Methylparaben Propylparaben Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-15

Description

Mineral oil 14% Petrolatum 74.9% Phenylephrine HCI 0.25%

Purpose

Protectant Vasoconstrictor


Medication Information

Purpose

Protectant

Vasoconstrictor

Description

Mineral oil 14% Petrolatum 74.9% Phenylephrine HCI 0.25%

Uses
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoid 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 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.
  • 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.
Questions?

Weekdays 9 AM to 4 PM EST 1-800-639-3803

Other Information

store at room temperature 68° - 77° F (20° - 25° C)

Active Ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCI 0.25%

Inactive Ingredients

beeswax, benzoic acid, cetyl alcohol, glycerol, methylparaben, polyoxyethylene lauryl ether, propylparaben, stearyl alcohol

When Using This Product

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

Ask A Doctor Or Pharmacist

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

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 Labeling: Hemorrhoidal Ointment, 1oz/28g

Package Labeling: Hemorrhoidal Ointment, 2oz/57g


Structured Label Content

Uses
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoid 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

Protectant

Vasoconstrictor

Warnings

For external 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.
  • 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.
Questions?

Weekdays 9 AM to 4 PM EST 1-800-639-3803

Other Information (Other information)

store at room temperature 68° - 77° F (20° - 25° C)

Active Ingredients (Active ingredients)

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCI 0.25%

Inactive Ingredients (Inactive ingredients)

beeswax, benzoic acid, cetyl alcohol, glycerol, methylparaben, polyoxyethylene lauryl ether, propylparaben, stearyl alcohol

When Using This Product (When using this product)

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

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

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

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 Labeling: Hemorrhoidal Ointment, 1oz/28g (Package Labeling: HEMORRHOIDAL OINTMENT, 1oz/28g)

Package Labeling: Hemorrhoidal Ointment, 2oz/57g (Package Labeling: HEMORRHOIDAL OINTMENT, 2oz/57g)


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