NIKZON HEMORRHOIDAL- 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 Genoma Lab USA Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                      Purpose

Phenylephrine HCL 0.25%.......................................... Vasconstrictor

Pramoxine HCL 1%.................................................... Local anesthetic

PURPOSE

Uses

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

WARNINGS

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use if you have

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

ASK DOCTOR/PHARMACIST

Ask a doctor of pharmacist before use if you are

• taking a prescription drug for high blood pressure or depression

WHEN USING

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

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

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

INDICATIONS & USAGE

Directions

• Remove cap from tube and puncture seal with opposite end of cap.
• 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.

STORAGE AND HANDLING

Other information

• Store at room temperature 20-25°C (68-77°F)
• Close cap tightly after use

INACTIVE INGREDIENT

Inactive ingredients

Aloe barbadensis leaf extract, Butylated hydroxytoluene, Cetostearyl alcohol, Cetyl esters, Cetyl palmitate, Distilled water, Glycerin, Glycerol monostearate, Isopropyl myristate, Lanolin, Methylparaben, Mineral oil, Polysorbate 60, Propylene glycol, Propylparaben, Sodium citrate hydrate, Stearic acid, Tocopherol acetate, White petrolatum

DOSAGE & ADMINISTRATION

Distributed by:

Genomma Lab USA Inc.

Houston, TX 77027

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NIKZON HEMORRHOIDAL 
phenylephrine hydrochloride, and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-423
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-423-25	1 in 1 CARTON	11/01/2016
1		25 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 final	part346	05/08/2015

Labeler - Genoma Lab USA Inc (832323534)