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

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topcare Hemorrhoidal

Topco Associates LLC

Topco Hemorrhoidal Ointment Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%

Shark liver oil 3.0%

Purpose

Protectant

Vasoconstrictor

topcare 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
  • trouble urinating due to an enlarged 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 the 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 pad
  • gently dry by patting or blotting with toilet 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
  • for intrarectal use:
  • remove cover from applicator and attach applicator to tube
  • lubricate applicator well, then gently insert applicator into the rectum
  • thoroughly clean applicator after each use and replace cover
  • also apply ointment to external area
  • children under 12 years of age: ask a doctor

topcare Hemorrhoidal Other information

store at 68°-77°F (20°-25°C)

Inactive ingredients

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

1-888-423-0139

Principal Display Panel

Medicated

Hemorrhoidal Ointment

Prevents Further Irritation

● Prompt Soothing Relief from Painful Burning, Itching and Discomfort

● Shrinks Swollen Hemorrhoidal Tissue

● Protects Irritated Tissue

● Relieves Internal and External Discomfort

Compare to Preparation H® Hemorrhoidal Ointment active ingredients

topcare Hemorrhoidal
Hemorrhoidal Ointment Carton Image #1 Hemorrhoidal Ointment Carton Image #2

topcare Hemorrhoidal

Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-400
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Mineral Oil 14 g
petrolatum 71.9 g
Phenylephrine Hydrochloride PHENYLEPHRINE 0.25 g
SHARK LIVER OIL 3 g

Inactive Ingredients

Ingredient Name Strength
YELLOW WAX
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
CORN OIL
GLYCERIN
LANOLIN
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:36800-400-16 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 1995-12-21


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Be sure to consult your doctor before taking any medication!
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