37a4cc43-0d53-f1bf-e063-6394a90a2dc9

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

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%


Medication Information

Warnings

Warnings

for external and / or intrarectal use only.

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
Purpose

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

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

Phenylephrine HCl 0.25%......Vasoconstrictor

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.
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

Description

Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%

Section 51945-4

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

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

Warnings

Warnings

for external and / or intrarectal use only.

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
Purpose

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

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

Phenylephrine HCl 0.25%......Vasoconstrictor

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.
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

Section 51945-4 (51945-4)

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

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


Advanced Ingredient Data


Raw Label Data

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