FDA Label for Hemorrhoidal

View Indications, Usage & Precautions

Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Valu Merchandisers, Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 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 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.


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 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 form applicator and attach tube, lubricate applicator well, then 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



Other information

Store at 20o to 25oC (68o to 77oF)


Inactive Ingredients



beeswax, benzoic acid, BHT, cocoa butter, cod liver oil, glycerin, lanolin, methylparaben, paraffin, propylparaben, purified water, squalane, thyme oil, tocopherol acetate


Active Ingredients



Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCL 0.25%


Purpose



Protectant

Protectant

Vasoconstrictor



Package Label



Best Choice Hemorrhoidal Ointment


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