Hemorrhoidex Ointment
FDA Label NDC 34666-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nartex Laboratorios Homeopaticos Sa De Cv for the product Hemorrhoidex (NDC 34666-201). 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, purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Ratanhia........................3X HPUS

Hamamelis....................1X HPUS

Purpose


Ratanhia........................3X HPUS........Hemorrhoids, pain after stool, burning in anus

Hamamelis....................1X HPUS.........Hemorrhoids, pulsation in rectum

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.  TINC is a homeopathic dilution: see www.nartexlabusa.com for details.

Uses

Temporarily relieves discomforting symptoms such as itching, burning, and swelling associated with hemorrhoids. Product Uses are based on Homeopathic Materia Medica. 
This product and its Uses have not been evaluated by the Food and Drug Administration.  This product has not been clinically tested by Nartex Labs USA, Inc.


Warnings

For external use only

Otc - Do Not Use

Do not use

  • if you have an allergy or hypersensitivity to components of the formula or if you have had a prior reaction to this product

Otc - Ask Doctor

Ask a doctor before use if you are

  •    under a doctor's care for any serious condition
  •    taking any other drug

Otc - When Using

When using this product

  • avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water
  • do not exceed the recommended daily dosage unless directed by physician

Otc - Stop Use

Stop use and ask a doctor if

  • bleeding occurs
  • symptoms persist, worse, or if new symptoms occur after 7 days
  • rash develops

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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.  Apply generously to affected area up to 2 times daily, especially at night, in the morning or after each bowel movement
  • reapply if needed
  • children under 12 years of age, consult a physician

Other Information

  • do not use if plastic seal around cap is broken or missing
  • store in a cool and dry place

Inactive Ingredients

Glycerin, Lanolin wax, Paraffin wax, Sodium benzoate, Water, White petrolatum

Description

Distributed by:

Nartex Labs USA, Inc.
11711 Memorial dr #685
Houston TX 77024
www.nartexlabusa.com

Principal Display Panel

HEMORRHOIDEX

ointment



Homeopathic Hemorrhoid Ointment

Net Wt. 1.0 oz (28.35g)





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