Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 30d26837-57e4-476c-9f5b-0171746fad2c
Routes
RECTAL TOPICAL
Published
Effective Date 2009-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Light Mineral Oil (140 mg) Petrolatum (719 mg) Phenylephrine (2.5 mg) Shark Liver Oil (30 mg)
Inactive Ingredients
Wax, Yellow Benzoic Acid Butylated Hydroxyanisole Corn Oil Glycerin Lanolin Methylparaben Paraffin Propylparaben Thymus Oil .alpha.-tocopherol Acetate, Dl- Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2005-07-01

Description

Mineral oil, 14% Petrolatum, USP 71.9% Phenylephrine HCI, 0.25% Shark liver oil, 3.0%

Purpose

Protectant Protectant Vasoconstrictor Protectant


Medication Information

Warnings and Precautions



Purpose

Protectant

Protectant

Vasoconstrictor

Protectant

Description

Mineral oil, 14% Petrolatum, USP 71.9% Phenylephrine HCI, 0.25% Shark liver oil, 3.0%

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

Section 42229-5



Section 50570-1


Section 53413-1



Warnings

For external and/or intrarectal use only.

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

Mineral oil, 14%



Petrolatum, USP 71.9%

Phenylephrine HCI, 0.25%

Shark liver oil, 3.0%

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.





Inactive Ingredients
beeswax, benzoic acid, BHA, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, thyme oil, tocopherol, water

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.

If Pregnant Or Breastfeeding

 ask a health professional before use.

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.
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

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.


Structured Label Content

Uses (USES)
  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily relieves itching, burning and discomfort associated with hemorrhoids

Warnings and Precautions (34071-1)



Section 42229-5 (42229-5)



Section 50570-1 (50570-1)


Section 53413-1 (53413-1)



Purpose (PURPOSE)

Protectant

Protectant

Vasoconstrictor

Protectant

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 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 Information (OTHER INFORMATION)
Store in a cool place or at room temperature but not over 86° F.
Active Ingredients (ACTIVE INGREDIENTS)

Mineral oil, 14%



Petrolatum, USP 71.9%

Phenylephrine HCI, 0.25%

Shark liver oil, 3.0%

Package Information (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.





Inactive Ingredients (INACTIVE INGREDIENTS)
beeswax, benzoic acid, BHA, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, thyme oil, tocopherol, water

When Using This Product (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.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

 ask a health professional before use.

Stop Use and Ask A Doctor If (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.
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.

Ask A Doctor Before Use If You Have (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 (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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