MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL ointment

mineral oil, petrolatum, phenylephrine hydrochloride, shark liver oil by

Drug Labeling and Warnings

mineral oil, petrolatum, phenylephrine hydrochloride, shark liver oil by is a Otc medication manufactured, distributed, or labeled by H and P Industries, Inc. dba Triad Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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

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.

INGREDIENTS AND APPEARANCE

MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL 
mineral oil, petrolatum, phenylephrine hydrochloride, shark liver oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50730-4536
Route of Administration	RECTAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
light mineral oil (UNII: N6K5787QVP) (light mineral oil - UNII:N6K5787QVP)	light mineral oil	140 mg  in 1 g
petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U)	petrolatum	719 mg  in 1 g
phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	phenylephrine hydrochloride	2.5 mg  in 1 g
shark liver oil (UNII: 4B24275HEU) (shark liver oil - UNII:4B24275HEU)	shark liver oil	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WAX, YELLOW (UNII: 2ZA36H0S2V)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CORN OIL (UNII: 8470G57WFM)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THYMUS OIL (UNII: M86Z5G7U0L)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50730-4536-0	1 in 1 BOX
1		56.7 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/01/2005

Labeler - H and P Industries, Inc. dba Triad Group (050259597)

Registrant - H and P Industries, Inc. dba Triad Group (050259597)

Establishment
Name	Address	ID/FEI	Business Operations
H and P Industries, Inc. dba Triad Group		050259597	manufacture