Hemorrhoidal
FDA Label NDC 54162-044

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Hemorrhoidal (NDC 54162-044). 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 ingredient                    purposemineral oil - 14%                   protectantpetrolatum - 71.9%              protectantphenylephrine - 0.25%          astringent, uses:, warnings:, when using this product:, stop use and ask a doctor if:, directions:, other information:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                    Purposemineral Oil - 14%                   Protectantpetrolatum - 71.9%              Protectantphenylephrine - 0.25%          Astringent

Uses:

  • Helps relieve local itching and discomfort with hemorrhoids.
  • Temporarily shrinks hemorrhoid tissues and relieves burning.
  • Temporarily provides a coating for relief of anorectal discomforts
  • Temporarily protects the inflamed, irritated anorectal surface to hlep make bowel movements less painful

Warnings:

For external and/or intrarectal use only

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

Directions:

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue.
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this ointment
  • Apply to 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, attach applicator to tube, lubricate applicator well and gently insert into the rectum.
    • Thoroughly cleanse applicator after each use
    • Also apply ointment to external area
    • Regular use provides continual therapy for relief of symptoms
    • Children under 12 years of age, consult a doctor

Other Information:

Store at room temperature but not over 80­° F
Lot No. & Exp Date: See tube

Inactive Ingredients:

Beeswax, benzoic acid, BHA, corn oil, glycern, lanolin alcohol, methyparaben, paraffin, propylparaben, shark liver oil, thyme, tocopherol, water.

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