Hemorrhoid Master Ointment
FDA Label NDC 72654-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ebanel Laboratories, Inc for the product Hemorrhoid Master (NDC 72654-002). 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 ingredient, purpose, uses, warnings, stop use and ask a doctor, when using this product, do not use, ask a doctor before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 4.00%

Phenylephrine HCl 0.25%

Purpose

Analgesic (Pain Relief)

(Vasoconstrictor)

Uses

  • Helps relieve the anorectal itching and discomfort in the perianal area.
  • Temporarily reduces swelling associated with irritation in hemorrhoids and other anorectal disorders.
  • Temporarily shrinks hemorrhoidal tissue.

Warnings

For external and or intrarectal use only.

Stop Use And Ask A Doctor

  • If condition worsens or does not improve within 7 days.
  • in case of bleeding. 
  • if allergic reaction to product occurs. If the symptoms being treated does not subside or if redness. irritation, swelling, pain, or other sympoms develop or increase.

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor.

Do Not Use

this product 

  • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
  • with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult doctor promptly.

Ask A Doctor Before Use

if you are

  • presently taking a prescription drug for high blood pressure or depression.

Keep Out Of Reach Of Children:

If swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

Adults: Apply to the affected area up to 3 times dialy.

  • Children under 12 years of age: consult a doctor.
  • When practical, clean affected area with mild soap and warm water and rinse thoroughly. Gently dry (patting or blotting) with tissue or soft cloth before use.
  • To use dispensing cap, attach it to tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

For Intrarectal Use:

Attach applicator to tube. Lubricate well, then gently insert applicator into the rectum.

For External use: Do not put this proudct into the rectum using fingers or any mechanical device.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cholecalciferol, Cholesterol, Diisopropyl Sebacate, Dimethyl Isosorbide, Dodecane, Ethoxydiglycol, Ethylhexylglycerin, Hexylene Glycol, Hydrocortisone, Isododecane, Isopropyl Myristate, Lecithin, Mentha Piperita (Peppermint) Oil, Microcrystalline Wax, Mineral Oil, Octyldodecanol, Panax Ginseng Root Extract, PEG-8 Dimethicone, Petrolatum, Phenoxyethanol, Phospholipids, Polyethylene, Polysorbate 80, Propylene Glycol, Punica Granatum Extract, Pyridoxine HCl, Retinyl Palmitate, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Zea Mays (Corn) Oil, Zinc Oxide.

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