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 Genoma Lab Usa Inc. 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 ingredients | Purpose |
|---|---|
| Phenylephrine HCl 0.25% | Vasoconstrictor |
| Pramoxine HCl 1% | Local anesthetic |
Uses
- For the temporary relief of anorectal itching, burning and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues, or piles.
Warnings
For external use only
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty urinating due to enlarged prostate gland.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for high blood pressure or depression.
Otc - When Using
When using this product
- 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.
Otc - Stop Use
Stop use and ask a doctor if
- rectal bleeding occurs
- an allergic reaction occurs
- the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
- condition worsens or does not improve within 7 days.
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
- Remove cap and lift foil safety seal from tube.
- Adults: When practical, cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
- Apply externally to the affected area with a thin layer up to 4 times daily.
- Children under 12 years of age: consult a doctor.
Other Information
- Store at room temperature 15-30°C (59-86°F)
- Close cap tightly after use.
Inactive Ingredients
Aloe Vera (Aloe Barbadensis) Extract, BHA, Carboxymethylcellulose Sodium, Cetearyl Alcohol, Citric Acid, Edetate Disodium, Glycerin, Glyceryl Stearate, Laureth 23, Methylparaben, Mineral Oil, Panthenol, Propyl Gallate, Propylene Glycol, Propylparaben, Sodium Benzoate, Steareth 2, Steareth 20, Stearyl Alcohol, Tocopherol (Natural Vitamin E), Vitamin E, Water (Purified), White Petrolatum, Xanthan Gum.
Questions?
1 877 99 GENOM (43666) Monday to Friday, 8 am to 6 pm Central time.
Principal Display Panel - 25 G Tube Box
Nikzon®
HEMORRHOIDAL
(ANORECTAL) CREAM
Temporary relief from:
– Pain– Itching– Inflammation
Net Wt. 0.9 Oz (25 g)
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