NIKZON HEMORRHOIDAL- glycerin, petrolatum, phenylephrine hydrochloride, and pramoxine hydrochloride cream

Nikzon Hemorrhoidal by

Drug Labeling and Warnings

Nikzon Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA, Quality CDMO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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 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.

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

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 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

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

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]

INGREDIENTS AND APPEARANCE

NIKZON HEMORRHOIDAL 
glycerin, petrolatum, phenylephrine hydrochloride, and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	144 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	150 mg  in 1 g
Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine hydrochloride	2.5 mg  in 1 g
Pramoxine hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine hydrochloride	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ceteareth-12 (UNII: 7V4MR24V5P)
glyceryl stearate SE (UNII: FCZ5MH785I)
mineral oil (UNII: T5L8T28FGP)
xanthan gum (UNII: TTV12P4NEE)
stearic acid (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-010-09	1 in 1 CARTON	07/07/2025
1		25.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M015	07/07/2025

Labeler - Genomma Lab USA (832323534)

Establishment
Name	Address	ID/FEI	Business Operations
Quality CDMO		117658386	MANUFACTURE(50066-010)