NDC 45802-050 Dibucaine
Ointment Topical

Product Information

Dibucaine is a human over the counter drug product labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is ointment and is administered via topical form.

Product Code45802-050
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Dibucaine
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Dibucaine
Product Type 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.
Human Otc Drug
Dosage FormOintment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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.
Padagis Israel Pharmaceuticals Ltd
Labeler Code45802
FDA Application Number 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.
part346
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-20-2011
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Dibucaine?


Product Packages

NDC 45802-050-03

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

Price per Unit: $0.14923 per GM

Product Details

What are Dibucaine Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • DIBUCAINE 1 g/100g - A local anesthetic of the amide type now generally used for surface anesthesia. It is one of the most potent and toxic of the long-acting local anesthetics and its parenteral use is restricted to spinal anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1006)

Dibucaine Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Dibucaine Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Dibucaine Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Dibucaine 1%


Purpose



Hemorrhoidal/topical analgesic


Uses



for hemorrhoidal:

  • •for the temporary relief of pain, itching and burning due to hemorrhoids and other anorectal disordersfor topical analgesic:
  • •for the temporary relief of pain and itching caused by sunburn, minor burns, minor cuts, scrapes, insect bites or minor skin irritation

Warnings



For external use only

Allergy warning: Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and ask a doctor.


Do Not Use



  • •in or near the eyes
  • •in infants under 2 years of age or weighing less than 35 pounds

When Using This Product



for hemorrhoidal:

  • •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

    for topical analgesic:

  • •do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use And Ask A Doctor If



for hemorrhoidal:

  • •condition worsens or does not improve within 7 days
  • •bleeding occurs
  • for topical analgesic:

    • •condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

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.


Directions



for hemorrhoidal:

  • •adults and children 12 years & older: when practical, clean 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 applying.
  • •apply externally to the affected area up to 3 or 4 times daily
  • •children under 12 years of age: ask a doctor
  • for topical analgesic:

    • •adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
    • •children under 2 years of age: ask a doctor

Other Information



store at 20°-25°C (68°-77°F)


Inactive Ingredients



acetone sodium bisulfite, lanolin, white petrolatum


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Child Resistant Packaging

Temporary Relief of Local Discomfort, Burning and Itching Associated with Inflamed Hemorrhoidal Tissues

Compare to Nupercainal® active ingredient

Dibucaine Ointment 1%

Hemorrhoidal & Topical Analgesic

NET WT 1 OZ (28 g)


* Please review the disclaimer below.