Pharmlitalia Hemorrhoid Fissure Treatment Ointment
FDA Label NDC 87947-002

6 label sections · Submitted to the FDA by Guangzhou Trading Financing Union Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Trading Financing Union Llc for the product Pharmlitalia Hemorrhoid Fissure Treatment (NDC 87947-002). 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 (per applicator)....................................purpose, uses, warnings, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Per Applicator)....................................Purpose

Aesculus hippocastanum 7X HPUS                                          Homeopathic*
Hamamelis virginiana 2X HPUS                                              Homeopathic*
Paeonia officinalis 2X HPUS                                                   Homeopathic*
Ratanhia 7X HPUS                                                                Homeopathic*

*HPUS indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

Temporarily relieves symptoms of hemorrhoids such as burning, itching, swelling, pain and discomfort.

Relieves hemorrhoid symptoms following childbirth.

Warnings

  • For rectal use only. 
  • Ask a doctor before use in case of bleeding. 
  • When using this product, do not exceed the recommended daily dosage. 
  • Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

Directions

  • Wash and dry the affected area. 
  • Remove the cap without squeezing the tube. 
  • Gently insert the rounded tip into the rectum and squeeze to administer the full dose. 
  • Slowly withdraw the applicator. 
  • Dispose of after single use. Do not flush. 
  • Wash hands thoroughly after use.

Inactive Ingredients

Aqua (Water), Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Centella Asiatica Leaf Extract, Aloe Barbadensis Leaf Extract, Borago Officinalis (Borage) Seed Oil, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Escin, Hypericum Perforatum Extract, Helichrysum Italicum (Everlasting) Flower Extract, Polysorbate 60, Dipotassium Glycyrrhizate, Lecithin, Tocopherol, Ascorbyl Palmitate, Citric Acid, Phenoxyethanol, Disodium EDTA, Ethylhexylglycerin.

Product Label

Image Description (Image 002)

Image Description (Image 002)

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