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.

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Nikzon®
Hemorrhoidal Cream

Drug Facts

Active ingredientsPurpose
Phenylephrine HCl 0.25%Vasoconstrictor
Pramoxine HCl 1%Local anesthetic

Uses

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

Other information

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.

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)

Principal Display Panel - 25 g Tube Box
NIKZON   HEMORRHOIDAL
phenylephrine hydrochloride and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-001
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 HYDROXYANISOLE (UNII: REK4960K2U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-001-011 in 1 BOX06/19/2019
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 FINALpart34612/01/2013
Labeler - Genoma Lab USA Inc (832323534)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(50066-001)

Revised: 11/2021
Document Id: 1cccdc0f-9ede-4ab3-b984-c552720dfe0b
Set id: e144fb04-db3c-4e22-9c9f-8378c7f0ce1f
Version: 2
Effective Time: 20211119
 
Genoma Lab USA Inc