93482a9b-145b-42d4-96db-599c281a39f1

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

Purpose

Protectant Vasoconstrictor

Description

Mineral oil 14% Petrolatum 74.9% Phenylephrine HCI 0.25%


Medication Information

Warnings

For external use only

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

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.
Other Information

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

Inactive Ingredients

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

Description

Mineral oil 14% Petrolatum 74.9% Phenylephrine HCI 0.25%

Questions?

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

Active Ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCI 0.25%

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

Warnings

For external use only

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

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.
Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Questions?

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

Active Ingredients (Active ingredients)

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCI 0.25%

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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