Topcare Hemorrhoidal
FDA Label NDC 36800-188

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Hemorrhoidal (NDC 36800-188). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Purposes

Protectant

Protectant

Vasoconstrictor

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

Other Information

  • store at 20-25oC (68-77oF)

Inactive Ingredients

bees wax, butylated hydroxytoluene, cod liver oil, glycerin, lanolin, methylparaben, paraffin wax, propylparaben, purified water, sodium benzoate, squalane, thyme oil, tocopherol acetate

Questions Or Comments?

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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

Image Of Carton Label (Hemorrhoidal1.new2013.tc)

Image Of Carton Label (Hemorrhoidal1.new2013.tc)

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