Mineral Oil, Petrolatum, Phenylephrine Hydrochloride, Shark Liver Oil
FDA Label NDC 50730-4536

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H And P Industries, Inc. Dba Triad Group for the product Mineral Oil, Petrolatum, Phenylephrine Hydrochloride, Shark Liver Oil (NDC 50730-4536). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Mineral oil, 14%

Petrolatum, USP 71.9%

Phenylephrine HCI, 0.25%

Shark liver oil, 3.0%

Purpose

Protectant

Protectant

Vasoconstrictor

Protectant

Uses

  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily relieves itching, burning and discomfort associated with hemorrhoids

Warnings

For external and/or intrarectal use only.


Ask A Doctor Before Use If You Have

  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If

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

When Using This Product

  • do not exceed the recommended daily dosage.
  • do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

Stop Use And Ask A Doctor If

  • you experience bleeding
  • condition worsens or does not improve within 7 days.
    • These may be signs of a serious condition.

If Pregnant Or Breastfeeding

 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.

Directions

Adults:
  • When practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this ointment.
  • Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
    • For intrarectal use:
    • Before applying, remove protective cover from applicator. Attach applicator to tube. Lubricate applicator well and then gently insert applicator into the rectum. Thoroughly clean applicator after each use and replace protective cover.
    • Also apply ointment to external area.
      • Children under 12 years:  ask a doctor.

Other


Other Information

Store in a cool place or at room temperature but not over 86° F.

Inactive Ingredients

Beeswax, benzoic acid, BHA, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, thyme oil, tocopherol, water

Otc - Questions


Package Information

TRIAD®

HEMORRHOIDAL
OINTMENT

Helps prevent further irritation
Temporarily shrinks hemorrhoids

  • Soothes itching, burning and discomfort associated with hemorrhoids
  • Temporarily shrinks hemorrhoids
  • For prompt temporary relief
    • Net wt.
    2 oz. (56.7 g)

    Manufactured by
    Triad Group, Inc.
    Brookfield, WI 53045
    MADE IN USA
    www.triad-group.net

    DO NOT USE IF SEAL UNDER CAP OF TUBE IS BROKEN OR MISSING WHEN PURCHASED.

    Carton (10 45336c A0906)

    Carton (10 45336c A0906)


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