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Nikzon Hemorrhoidal by Genoma Lab USA Inc

Medically reviewed on July 5, 2017

Dosage form: cream
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1g, PRAMOXINE HYDROCHLORIDE 10mg in 1g
Labeler: Genoma Lab USA Inc
NDC Code: 50066-423

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients                                                      Purpose

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

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 of 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 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.

Other information

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

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

Distributed by:

Genomma Lab USA Inc.

Houston, TX 77027

Made in Korea

NIKZON HEMORRHOIDAL 
phenylephrine hydrochloride, and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-423
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BUTYLATED HYDROXYTOLUENE 
CETOSTEARYL ALCOHOL 
CETYL ESTERS WAX 
CETYL PALMITATE 
WATER 
GLYCERIN 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
LANOLIN 
METHYLPARABEN 
MINERAL OIL 
POLYSORBATE 60 
PROPYLENE GLYCOL 
PROPYLPARABEN 
TRISODIUM CITRATE DIHYDRATE 
STEARIC ACID 
ALPHA-TOCOPHEROL ACETATE 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:50066-423-251 TUBE in 1 CARTON
125 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/08/2015
Labeler - Genoma Lab USA Inc (832323534)

 
Genoma Lab USA Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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