NDC 57896-131 Dibucaine

Dibucaine 1%

NDC Product Code 57896-131

NDC 57896-131-01

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

NDC Product Information

Dibucaine with NDC 57896-131 is a a human over the counter drug product labeled by Geri-care Pharmaceuticals, Corp. The generic name of Dibucaine is dibucaine 1%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Geri-care Pharmaceuticals, Corp

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.

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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • LANOLIN (UNII: 7EV65EAW6H)

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.
  • 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: Geri-care Pharmaceuticals, Corp
Labeler Code: 57896
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 09-22-2020 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 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%

Otc - Purpose

Hemorrhoidal Ointment

Indications & Usage

Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders.

If Pregnant Or Breast-Feeding

Ask a health care professional before use.

Stop Use And Ask A Doctor

  • Bleeding occursCondition worsens or does not improve within 7 days

Keep Out Of The Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

In or near eyesIn children under 2 years of age

Warnings

For External use onlyAllergy alertCertain persons can develop allergic reactions to ingredients in this product.If the symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and ask a doctor.

When Using This Product

Do not use more than directed unless directed by a doctorDo not put this product into the rectum by using fingers or any mechanical device or applicator.

Directions

  • Adults and children 12 years of age or older. If possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toilet tissue or a soft cloth before applying.Apply externally to the affected area up to 3 to 4 times daily.Children under 12 years of age. ask a doctor

Other Information

  • Store at 20º-25ºC (68º-77ºF)Tamper-evident; do not use if foil seal is broken or missing

Inactive Ingredients

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Distributed By

Geri-Care Pharmaceuticals Corp.1650 63rd StreetBrooklyn, NY 112041-800-540-3765Product of China* This product is not manufactured or distributed by the owner of the registered trademark Nupercainal®

* Please review the disclaimer below.