NIKZON HEMORRHOIDAL- phenylephrine hydrochloride and pramoxine hydrochloride cream

Nikzon by

Drug Labeling and Warnings

Nikzon by is a Otc medication manufactured, distributed, or labeled by Genoma Lab USA Inc, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Phenylephrine HCl 0.25%	Vasoconstrictor
Pramoxine HCl 1%	Local anesthetic

Uses

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

Warnings

For external use only

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

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 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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Remove cap and lift foil safety seal from tube.
• 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.

Other information

• Store at room temperature 15-30°C (59-86°F)
• Close cap tightly after use.

Inactive ingredients

Aloe Vera (Aloe Barbadensis) Extract, BHA, Carboxymethylcellulose Sodium, Cetearyl Alcohol, Citric Acid, Edetate Disodium, Glycerin, Glyceryl Stearate, Laureth 23, Methylparaben, Mineral Oil, Panthenol, Propyl Gallate, Propylene Glycol, Propylparaben, Sodium Benzoate, Steareth 2, Steareth 20, Stearyl Alcohol, Tocopherol (Natural Vitamin E), Vitamin E, Water (Purified), White Petrolatum, Xanthan Gum.

Questions?

1 877 99 GENOM (43666) Monday to Friday, 8 am to 6 pm Central time.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 25 g Tube Box

Nikzon®

HEMORRHOIDAL
(ANORECTAL) CREAM

Temporary relief from:

• – Pain
• – Itching
• – Inflammation

Net Wt. 0.9 Oz (25 g)

INGREDIENTS AND APPEARANCE

NIKZON   HEMORRHOIDAL
phenylephrine hydrochloride and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-001
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-23 (UNII: N72LMW566G)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-001-01	1 in 1 BOX
1		25 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	12/01/2013

Labeler - Genoma Lab USA Inc (832323534)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(50066-001)