NIKZON HEMORRHOIDAL- phenylephrine hydrochloride, and pramoxine hydrochloride cream 
Genoma Lab USA Inc

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.

----------

Nikzon Hemorrhoidal 0.9oz (66000, 2018)

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

66000

NIKZON HEMORRHOIDAL 
phenylephrine hydrochloride, and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-423
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LANOLIN (UNII: 7EV65EAW6H)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-423-251 in 1 CARTON11/01/2016
125 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/08/201510/16/2019
Labeler - Genoma Lab USA Inc (832323534)

Revised: 10/2021
 
Genoma Lab USA Inc