NDC 50066-423 Nikzon Hemorrhoidal

Phenylephrine Hydrochloride, And Pramoxine Hydrochloride

NDC Product Code 50066-423

NDC 50066-423-25

Package Description: 1 TUBE in 1 CARTON > 25 g in 1 TUBE

NDC Product Information

Nikzon Hemorrhoidal with NDC 50066-423 is a a human over the counter drug product labeled by Genoma Lab Usa Inc. The generic name of Nikzon Hemorrhoidal is phenylephrine hydrochloride, and pramoxine hydrochloride. The product's dosage form is cream and is administered via topical form.

Labeler Name: Genoma Lab Usa Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Nikzon Hemorrhoidal Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g
  • PRAMOXINE HYDROCHLORIDE 10 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LANOLIN (UNII: 7EV65EAW6H)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Genoma Lab Usa Inc
Labeler Code: 50066
FDA Application Number: part346 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-08-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Nikzon Hemorrhoidal Product Label Images

Nikzon Hemorrhoidal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredients                                                      PurposePhenylephrine HCL 0.25%.......................................... VasconstrictorPramoxine HCL 1%.................................................... Local anesthetic

Otc - Purpose

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

Warnings

WarningsFor external use only

Otc - Ask Doctor

  • Ask a doctor before use if you haveheart diseasehigh blood pressurethyroid diseasediabetesdifficulty urinating due to enlarged prostate gland

Otc - Ask Doctor/Pharmacist

  • Ask a doctor of pharmacist before use if you aretaking a prescription drug for high blood pressure or depression

Otc - When Using

  • When using this productdo not exceed the recommended daily dosage unless directed by a doctordo not put this product into the rectum by using fingers or any mechanical device or applicator

Otc - Stop Use

  • Stop use and ask a doctor ifrectal bleeding occursan allergic reaction occursthe symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increasecondition worsens or does not improve within 7 days

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

  • DirectionsRemove 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.

Storage And Handling

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

Inactive Ingredient

Inactive ingredientsAloe 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

Dosage & Administration

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

* Please review the disclaimer below.