NDC 45802-050 Dibucaine

Dibucaine

NDC Product Code 45802-050

NDC 45802-050-03

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

NDC Product Information

Dibucaine with NDC 45802-050 is a a human over the counter drug product labeled by Perrigo New York Inc. The generic name of Dibucaine is dibucaine. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Perrigo New York Inc

Dosage Form: Ointment - 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.

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.

Dibucaine 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.

  • DIBUCAINE 1 g/100g

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.

  • ACETONE SODIUM BISULFITE (UNII: 47VY054OXY)
  • LANOLIN (UNII: 7EV65EAW6H)
  • 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: Perrigo New York Inc
Labeler Code: 45802
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: 06-20-2011 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dibucaine Product Label Images

Dibucaine 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

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 onlyAllergy 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 applicatorfor 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 occursfor 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 doctorfor 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

* Please review the disclaimer below.