NIKZON HEMORRHOIDAL- glycerin, petrolatum, phenylephrine hydrochloride, and pramoxine hydrochloride cream 
Genomma Lab USA

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Nikzon® Hemorrhoidal Cream

Drug Facts

Active ingredientsPurpose
Glycerin 14.4%Protectant
Petrolatum 15%Protectant
Phenylephrine HCl 0.25%Vasoconstrictor
Pramoxine HCl 1%Local Anesthetic

Uses

Warnings

For external use only.

Do not use this product

  • in the eyes or nose
  • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not apply to large areas of the body
  • 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 physician if

  • bleeding occurs
  • the condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or redness, irritation, swelling or pain develops, persists, or increases

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Other Information

Inactive ingredients

BHA, cetyl alcohol, citric acid, decolorized aloe vera barbadensis leaf juice, disodium EDTA, glycerin, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, petrolatum, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (vitamin E) acetate, xanthan gum

Questions or comments?

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 - 25.5 g Tube Carton

Nikzon®

HEMORRHOIDAL
(ANORECTAL) CREAM

Temporary relief from:

Net Wt. 0.9 Oz (25.5 g)

PRINCIPAL DISPLAY PANEL - 25.5 g Tube Carton
NIKZON HEMORRHOIDAL 
glycerin, petrolatum, phenylephrine hydrochloride, and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin144 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum150 mg  in 1 g
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
water (UNII: 059QF0KO0R)  
cetyl alcohol (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
mineral oil (UNII: T5L8T28FGP)  
xanthan gum (UNII: TTV12P4NEE)  
propylene glycol (UNII: 6DC9Q167V3)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-010-091 in 1 CARTON11/01/2024
125.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01511/01/2024
Labeler - Genomma Lab USA (832323534)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex, LLC062808196MANUFACTURE(50066-010)

Revised: 11/2024
Document Id: 154ecda3-0fe9-4d0e-a927-b0ab94a100c3
Set id: 8f9a9939-2c99-489f-b597-9a51ec2684f9
Version: 1
Effective Time: 20241101
 
Genomma Lab USA