NDC 53329-031 Curad Maximum Strength Triple Antibiotic

Bacitracin, Neomycin, Polymyxin B, Pramoxine Hydrochloride

NDC Product Code 53329-031

NDC CODE: 53329-031

Proprietary Name: Curad Maximum Strength Triple Antibiotic 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.

Non-Proprietary Name: Bacitracin, Neomycin, Polymyxin B, Pramoxine Hydrochloride 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Drug uses not available
  • This medication is used to decrease the risk of infection after certain intestinal surgeries. Neomycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria in the intestines. Neomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition is caused by too much of a certain natural substance (ammonia). Normally, the liver gets rid of ammonia, but liver disease can cause too much ammonia to build up in the body. This medication helps treat encephalopathy by killing certain intestinal bacteria that make ammonia. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

NDC Code Structure

  • 53329 - Medline Industries, Inc.
    • 53329-031 - Curad Maximum Strength Triple Antibiotic

NDC 53329-031-01

Package Description: 1 TUBE in 1 BOX > 28.4 g in 1 TUBE

NDC Product Information

Curad Maximum Strength Triple Antibiotic with NDC 53329-031 is a a human over the counter drug product labeled by Medline Industries, Inc.. The generic name of Curad Maximum Strength Triple Antibiotic is bacitracin, neomycin, polymyxin b, pramoxine hydrochloride. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Medline Industries, 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.

Curad Maximum Strength Triple Antibiotic 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.

  • BACITRACIN ZINC 500 [USP'U]/g
  • POLYMYXIN B SULFATE 10000 [USP'U]/g
  • NEOMYCIN SULFATE 3.5 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.

  • 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.
  • 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: Medline Industries, Inc.
Labeler Code: 53329
FDA Application Number: part333B 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: 12-01-2019 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.

Curad Maximum Strength Triple Antibiotic Product Label Images

Curad Maximum Strength Triple Antibiotic 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 Ingredients (In Each Gram)

Bacitracin 500 unitsNeomycin 3.5 mgPolymyxin B 10,000 unitsPramoxin hydrochloride 10 mg

Purposes

First aid antibioticFirst aid antibioticFirst aid antibioticPain reliever

Uses

  • First aid to help prevent infection in and temporarily relieves pain due tominor cutsscrapesburns

Warnings

  • For external use only

Do Not Use

  • If allergic to any of the ingredientsin or near the eyeson large areas of the body

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsanimal bitesserious burns

Stop Use And Ask A Doctor If

  • You need to use longer than 1 weekcondition lasts or gets worsesymptoms last for more than 7 days, or clear up and come back within a few daysa rash or other allergic reaction develops

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 2 years and older:clean affected areaapply a small amount (equal to the surface area of tip of finger) on area 1 to 3 times dailymay be covered with a sterile bandage.Children under 2 years: ask a doctor

Other Information

Store at controlled room temperature 68º-77ºF (20º-25ºC).

Inactive Ingredient

Petrolatum

Other

©2019 CURAD and Medline are registered trademarks of Medline Industries, Inc. Manufactured for Medline Industries, Inc., Three Lakes Drive Northfield, IL 60093 USA. Made in USA of domestic and imported materials.

1-800-633-5463 RB19SFZ

* Please review the disclaimer below.