Label: NIKZON HEMORRHOIDAL- glycerin, petrolatum, phenylephrine hydrochloride, and pramoxine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

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

    • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream
    • apply externally to the affected area up to 4 times daily or after each bowel movement
    • children under 12 years old: consult a physician
  • Other Information

    • store at 15 to 30ºC (59 to 86ºF)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
  • 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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 25.5 g Tube Carton

    Nikzon®

    HEMORRHOIDAL
    (ANORECTAL) CREAM

    Temporary relief from:

    • Pain
    • Itching
    • Inflammation

    Net Wt. 0.9 Oz (25.5 g)

    PRINCIPAL DISPLAY PANEL - 25.5 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    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)
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