SPL v2
SPL
SPL Set ID 37a4cc43-0d53-f1bf-e063-6394a90a2dc9
Routes
TOPICAL RECTAL
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (74.9 g) Phenylephrine (0.25 g) Mineral Oil (14 g)
Inactive Ingredients
Water .alpha.-tocopherol Acetate Propylparaben Lanolin Paraffin White Wax Benzoic Acid Lanolin Alcohols Thyme Oil Butylated Hydroxyanisole Corn Oil Methylparaben Glycerin

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-16

Description

Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%

Purpose

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


Medication Information

Purpose

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

Uses

  • helps relieve the local ithcing and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue and relieves burning
  • temporarity 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

Warnings

for external and / or intrarectal use only.

Directions

Directions

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Genrly dry by patting or blotting with toilet tissue or a soft cloth before applying ointment.
  • INTERARECTAL 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 the cover.
  • EXTERNAL USE: apply to affected area
  • Apply to affected area up to 4 times daily
  • Children under 12 yeras of age: consult a doctor.
Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Inactive Ingredients

Inactive ingredients: Benzoic Acid, Betylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, Lanolin Alcohols, Methylparaben, Mineral Oil, Paraffin, Propylparaben, Purifed Water, Thyme Oil, Vitamin E, 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 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 Doctor Before Use If You Have

Ask 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

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

Uses

  • helps relieve the local ithcing and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue and relieves burning
  • temporarity 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

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

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

Phenylephrine HCl 0.25%......Vasoconstrictor

Warnings

Warnings

for external and / or intrarectal use only.

Directions

Directions

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Genrly dry by patting or blotting with toilet tissue or a soft cloth before applying ointment.
  • INTERARECTAL 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 the cover.
  • EXTERNAL USE: apply to affected area
  • Apply to affected area up to 4 times daily
  • Children under 12 yeras of age: consult a doctor.
Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Inactive Ingredients (Inactive ingredients)

Inactive ingredients: Benzoic Acid, Betylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, Lanolin Alcohols, Methylparaben, Mineral Oil, Paraffin, Propylparaben, Purifed Water, Thyme Oil, Vitamin E, White Wax

When Using This Product (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)

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)

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

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)

Ask Doctor Before Use If You Have (Ask doctor before use if you have)

Ask 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 (Ask a doctor or pharmacist before use if you)

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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