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hemorrhoidal

Publix Super Markets Inc

Publix Super Markets, Inc. Hemorrhoidal Ointment Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%

Purposes

Protectant

Vasoconstrictor

hemorrhoidal Uses

  • •helps relieve the local itching and discomfort associated with hemorrhoids
  • •temporarily shrinks hemorrhoidal tissue and relieves burning
  • •temporarily provides a coating for relief of anorectal discomforts
  • •temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For external and/or intrarectal use only

Ask a 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 are

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

When using this product

do not exceed the recommended daily dosage unless directed by a doctor

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,

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. (1-800-222-1222)

Directions

  • •adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment.
  • •when first opening the tube, puncture foil seal with top end of cap
  • •apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • •intrarectal 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 cover
  • •also apply ointment to external area
  • •regular use provides continual therapy for relief of symptoms
  • •children under 12 years of age: ask a doctor

Inactive ingredients

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, shark liver oil, thymus vulgaris (thyme) oil, tocopheryl acetate, white wax

Package/Label Principal Display Panel

hemorrhoidal ointment

RECTAL OINTMENT

reduces swelling

protects irritated tissue

relieves painful itching and burning

Compare to the Active Ingredients in Preparation H® Hemorrhoidal Ointment

hemorrhoidal

Mineral oil, petrolatum, phenylephrine hcl OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:56062-678
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Mineral Oil 140.000 mg
petrolatum 719.000 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.500 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
CORN OIL
GLYCERIN
LANOLIN
Lanolin Alcohols
METHYLPARABEN
PARAFFIN
PROPYLPARABEN
water
SHARK LIVER OIL
THYME OIL
.ALPHA.-TOCOPHEROL ACETATE
white wax

Product Characteristics

Color
YELLOW

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28 in 1 TUBE
2 NDC:56062-678-64 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2012-11-19


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Be sure to consult your doctor before taking any medication!
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