Nikzon®

Nikzon®
SPL v2
SPL
SPL Set ID 8f9a9939-2c99-489f-b597-9a51ec2684f9
Route
TOPICAL
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (144 mg) Petrolatum (150 mg) Phenylephrine (2.5 mg) Pramoxine (10 mg)
Inactive Ingredients
Water Ceteareth-12 Glyceryl Stearate Se Mineral Oil Xanthan Gum Stearic Acid

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-07

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • for the temporary relief of anorectal itching and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues, or piles
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients Purpose
Glycerin 14.4% Protectant
Petrolatum 15% Protectant
Phenylephrine HCl 0.25% Vasoconstrictor
Pramoxine HCl 1% Local Anesthetic
Warnings

For external use only.

Directions
  • Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet 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 doctor.
Other Information
  • Store at 20 to 25°C (68 to 77°F).
  • Close cap tightly after use.
Inactive Ingredients

Aloe Barbadensis Leaf Extract, Butylated Hydroxytoluene, Ceteareth-12, Glyceryl Stearate SE, Mineral Oil, Panthenol, Phenoxyethanol, Purified Water, Sodium hydroxide, Stearic Acid, Vitamin E, Xanthan Gum.

Questions Or Comments?

US 1-877-994-3666 Monday to Friday from 8 AM to 6 PM, Central time. Dominican Republic:18887600140

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.
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 Doctor 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 increase. persists, or increases.
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]

Ask A Doctor Or Pharmacist Before Use If You Are
  • presently taking a prescription drug for high blood pressure or depression.

Structured Label Content

Uses
  • for the temporary relief of anorectal itching and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues, or piles
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients Purpose
Glycerin 14.4% Protectant
Petrolatum 15% Protectant
Phenylephrine HCl 0.25% Vasoconstrictor
Pramoxine HCl 1% Local Anesthetic
Warnings

For external use only.

Directions
  • Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet 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 doctor.
Other Information
  • Store at 20 to 25°C (68 to 77°F).
  • Close cap tightly after use.
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Butylated Hydroxytoluene, Ceteareth-12, Glyceryl Stearate SE, Mineral Oil, Panthenol, Phenoxyethanol, Purified Water, Sodium hydroxide, Stearic Acid, Vitamin E, Xanthan Gum.

Questions Or Comments? (Questions or comments?)

US 1-877-994-3666 Monday to Friday from 8 AM to 6 PM, Central time. Dominican Republic:18887600140

Do Not Use This Product (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.
When Using This Product (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 Doctor If (Stop use and ask a doctor 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 increase. persists, or increases.
Principal Display Panel 25.5 G Tube Carton (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]

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • presently taking a prescription drug for high blood pressure or depression.

Advanced Ingredient Data


Raw Label Data

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