FDA Label for Mineral Oil, Petrolatum, Phenylephrine Hydrochloride, Shark Liver Oil

View Indications, Usage & Precautions

Mineral Oil, Petrolatum, Phenylephrine Hydrochloride, Shark Liver Oil Product Label

The following document was submitted to the FDA by the labeler of this product H And P Industries, Inc. Dba Triad Group. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.



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