NDC 0536-1211 Dibucaine Topical Anesthetic 1% Hemorrhoidal

Dibucaine

NDC Product Code 0536-1211

NDC 0536-1211-95

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

NDC Product Information

Dibucaine Topical Anesthetic 1% Hemorrhoidal with NDC 0536-1211 is a a human over the counter drug product labeled by Rugby Laboratories Inc.. The generic name of Dibucaine Topical Anesthetic 1% Hemorrhoidal is dibucaine. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Rugby Laboratories 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 Topical Anesthetic 1% 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.

  • DIBUCAINE 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.

  • LANOLIN (UNII: 7EV65EAW6H)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • WATER (UNII: 059QF0KO0R)
  • 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: Rugby Laboratories Inc.
Labeler Code: 0536
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: 08-19-2019 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: 12-31-2020 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 Topical Anesthetic 1% Hemorrhoidal Product Label Images

Dibucaine Topical Anesthetic 1% 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

​Active Ingredient

Dibucaine 1%

​Purpose

Hemmorhoidal ointment

​Use

  • Temporarily relieves pain and itching due to hemorrhoids and other anorectal disorders

​Warnings

​For external use only.

Allergy Alert

  • Certain persons can develop allergic reactions to ingredients in this product.  If the symptoms being treated does not subside or if redness, irritaion, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

Do Not Use

  • In or near the eyesin children under 2 years of age

When Using This Product

  • Do not use more than directed 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 Doctor If

  • Bleeding occurscondition worsens or does not improve

If Pregnant Or Breast-Feeding

Ask a health care professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center right away.

​Directions

  • Adults and children 12 years and over:  If possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or 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 20-25
  • ​o​C (68-77
  • ​o​F)
  • Tamper-evident:  do not use if foil seal is broken or missing

Other

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

* Please review the disclaimer below.