FDA.reportPublic FDA data

Nikzon ® Hemorrhoidal Cream

Manufacturer
Genomma Lab USA | Quality CDMO
Effective date
2025-07-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:07:17

Label at a glance#

ProductNikzon Hemorrhoidal
Active ingredientGlycerin, Petrolatum, Phenylephrine hydrochloride, Pramoxine hydrochloride
Label structure10 sections

Indications and uses

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

Dosage and administration

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.

Storage and handling

Store at 20 to 25°C (68 to 77°F). Close cap tightly after use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not use this product

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • Store at 20 to 25°C (68 to 77°F).
  • Close cap tightly after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
U.S.: Genomma Lab USA Inc., Houston, TX 77098.

PRINCIPAL DISPLAY PANEL - 25.5 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN2
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD2
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-010-09Nikzon Hemorrhoidal25.5 g in 1 TUBECREAM25.52
50066-010-09Nikzon Hemorrhoidal1 in 1 CARTONCREAM12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-01050066-010-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GlycerinPDC6A3C0OXACTIB
Petrolatum4T6H12BN9UACTIB
Phenylephrine hydrochloride04JA59TNSJACTIB
Pramoxine hydrochloride88AYB867L5ACTIB
water059QF0KO0RIACT
ceteareth-127V4MR24V5PIACT
glyceryl stearate SEFCZ5MH785IIACT
mineral oilT5L8T28FGPIACT
xanthan gumTTV12P4NEEIACT
stearic acid4ELV7Z65APIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
ndc (package): 50066-010-09
ndc (product): 50066-010
ndc11 (package): 50066001009
spl id: 6be21f1f-a1cc-40cc-82ab-a663264c640c
spl set id: 8f9a9939-2c99-489f-b597-9a51ec2684f9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.