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, Natureplex, LLC. 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 physician 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 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 a 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 physician

Other Information

• store at 15 to 30ºC (59 to 86ºF)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

BHA, cetyl alcohol, citric acid, decolorized aloe vera barbadensis leaf juice, disodium EDTA, glycerin, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, petrolatum, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (vitamin E) acetate, xanthan gum

Questions or comments?

1 877 99 GENOM (43666) Monday to Friday, 8 AM to 6 PM Central time

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

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)
cetyl alcohol (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
mineral oil (UNII: T5L8T28FGP)
xanthan gum (UNII: TTV12P4NEE)
propylene glycol (UNII: 6DC9Q167V3)

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	11/01/2024
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	11/01/2024

Labeler - Genomma Lab USA (832323534)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex, LLC		062808196	MANUFACTURE(50066-010)