Nikzon Hemorrhoidal Cream
FDA Label NDC 50066-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Nikzon Hemorrhoidal (NDC 50066-010). 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 other, otc - purpose, uses, warnings, do not use this product, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a physician if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: Genomma Lab USA, Inc., Houston, TX, 77027

Otc - Purpose

Active ingredientsPurpose
Glycerin 14.4%Protectant
Petrolatum 15%Protectant
Phenylephrine HCl 0.25%Vasoconstrictor
Pramoxine HCl 1%Local Anesthetic

Uses

  • for the temporary relief of anorectal itching and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues, or piles

Warnings

For external use only.

Do Not Use This Product

  • in the eyes or nose
  • 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.

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 apply to large areas of the body
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Physician If

  • bleeding occurs
  • the condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or redness, irritation, swelling or pain develops, persists, or increases

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: 800-222-1222.

Directions

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream
  • apply externally to the affected area up to 4 times daily or after each bowel movement
  • children under 12 years old: consult a physician

Other Information

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive Ingredients

BHA, cetyl alcohol, citric acid, decolorized aloe vera barbadensis leaf juice, disodium EDTA, glycerin, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, petrolatum, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (vitamin E) acetate, xanthan gum

Questions Or Comments?

1 877 99 GENOM (43666) Monday to Friday, 8 AM to 6 PM Central time

Principal Display Panel - 25.5 G Tube Carton

Nikzon®

HEMORRHOIDAL
(ANORECTAL) CREAM

Temporary relief from:

  • Pain
  • Itching
  • Inflammation

    • Net Wt. 0.9 Oz (25.5 g)

    Principal Display Panel (25.5 g Tube Carton)

    Principal Display Panel (25.5 g Tube Carton)

* Please review the disclaimer below.