FDA Label for Nikzon Hemorrhoidal

View Indications, Usage & Precautions

Nikzon Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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:

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