SPL v5
SPL
SPL Set ID 7913bd41-a606-4ca6-b69f-2717c2f54b07
Route
TOPICAL
Published
Effective Date 2023-10-19
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
Benzoic Acid Butylated Hydroxyanisole Corn Oil Glycerin Lanolin Lanolin Alcohols Methylparaben Paraffin Propylparaben Water Thyme Oil .alpha.-tocopherol Acetate White Wax

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-01

Description

Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%

Purpose

Active Ingredients Purposes Mineral Oil 14%...................................................................Protectant Petrolatum 74.9%................................................................Protectant Phenylephrine HCl 0.25%...............................................Vasoconstrictor


Medication Information

Purpose

Active Ingredients Purposes

Mineral Oil 14%...................................................................Protectant

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

Phenylephrine HCl 0.25%...............................................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 51945-4

Warnings

For external and/or intrarectal 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 arepresently 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 improved within 7 days

▪ introduction of applicator into the rectum causes additional pain

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

Directions

A dults:when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toliet tissue or a soft cloth before applying ointment

  • 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
  • EXTERNAL USE: apply to affected area
  • Apply to affected areas up to 4 times daily

Children under 12 years of age: consult a doctor

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Inactive Ingredients

Benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thyme oil, Vitamin E, white wax

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)


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)

Purpose

Active Ingredients Purposes

Mineral Oil 14%...................................................................Protectant

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

Phenylephrine HCl 0.25%...............................................Vasoconstrictor

Warnings

For external and/or intrarectal 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 arepresently 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 improved within 7 days

▪ introduction of applicator into the rectum causes additional pain

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

Directions

A dults:when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toliet tissue or a soft cloth before applying ointment

  • 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
  • EXTERNAL USE: apply to affected area
  • Apply to affected areas up to 4 times daily

Children under 12 years of age: consult a doctor

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Inactive Ingredients

Benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thyme oil, Vitamin E, white wax

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)