Hemorrhoidal description, usages, side effects, indications, overdosage, supplying and lots more!

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Hemorrhoidal

Qualitest Pharmaceuticals

Hemorrhoidal Ointment


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Mineral oil, USP 14%

Phenylephrine HCl, USP 0.25%

Shark liver oil 3.0%

White Petrolatum, USP 71.9%

Protectant

Vasoconstrictor

Protectant

Protectant

  • 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

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.

Adults and children 12 years and older:

  • 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, unscrew the cap, use pointed end on cap to puncture seal
  • 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: ask a doctor

  • store at 15° to 30°C (59° to 86°F)
  • for lot number and expiration date, see crimp of tube or see box

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

beeswax, benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, purified water, thyme oil, tocopherol

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 1/10 R4
8265485  0520

PRINCIPAL DISPLAY PANEL

Hemorrhoidal

Hemorrhoidal

mineral oil and phenylephrine hcl and shark liver oil and white petrolatum OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0603-0520
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Mineral Oil 140 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg
SHARK LIVER OIL 30 mg
petrolatum 719 mg

Inactive Ingredients

Ingredient Name Strength
YELLOW WAX
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
CORN OIL
GLYCERIN
LANOLIN
Lanolin Alcohols
METHYLPARABEN
PARAFFIN
PROPYLPARABEN
water
THYME OIL
ALPHA-TOCOPHEROL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 57 in 1 TUBE
2 NDC:0603-0520-52 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 1997-08-01


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Be sure to consult your doctor before taking any medication!
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