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Nikzon

Genoma Lab USA Inc

Nikzon Hemorrhoidal Cream


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Phenylephrine HCl 0.25% Vasoconstrictor
Pramoxine HCl 1% Local anesthetic

Nikzon 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

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty urinating due to enlarged prostate gland.

Ask a doctor or pharmacist before use if you are

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

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.

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.

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.

Nikzon 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.

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

PRINCIPAL DISPLAY PANEL - 25 g Tube Box

Nikzon ®

HEMORRHOIDAL
(ANORECTAL) CREAM

Temporary relief from:

  • –Pain
  • –Itching
  • –Inflammation

Net Wt. 0.9 Oz (25 g)

Nikzon

Nikzon

PHENYLEPHRINE HYDROCHLORIDE and PRAMOXINE HYDROCHLORIDE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50066-001
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg
pramoxine hydrochloride PRAMOXINE 10 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
BUTYLATED HYDROXYANISOLE
CARBOXYMETHYLCELLULOSE SODIUM
CETOSTEARYL ALCOHOL
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
GLYCERIN
GLYCERYL MONOSTEARATE
laureth-23
METHYLPARABEN
Mineral Oil
PANTHENOL
PROPYL GALLATE
propylene glycol
PROPYLPARABEN
SODIUM BENZOATE
STEARETH-2
Steareth-20
stearyl alcohol
Tocopherol
.ALPHA.-TOCOPHEROL
water
petrolatum
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 TUBE
2 NDC:50066-001-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2013-12-01


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Be sure to consult your doctor before taking any medication!
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