NDC 61010-4400 Triple Antibiotic
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
NDC Product Code 61010-4400
Proprietary Name: 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 Zinc, Neomycin Sulfate, Polymyxin B Sulfate 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 InformationThe 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.
- 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.
- Drug uses not available
NDC Code Structure
- 61010 - Safetec Of America, Inc.
- 61010-4400 - Triple Antibiotic
NDC 61010-4400-1
Package Description: 28.4 g in 1 TUBE
NDC Product Information
Triple Antibiotic with NDC 61010-4400 is a a human over the counter drug product labeled by Safetec Of America, Inc.. The generic name of Triple Antibiotic is bacitracin zinc, neomycin sulfate, polymyxin b sulfate. The product's dosage form is ointment and is administered via topical form.
Labeler Name: Safetec Of America, 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.
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.
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.
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Safetec Of America, Inc.
Labeler Code: 61010
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: 11-01-2019 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: 12-31-2021 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.
Triple Antibiotic Product Label Images
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
- Other
- Active Ingredients (In Each Gram)
- Purpose
- Uses
- Warnings
- Do Not Use
- Otc - Ask Doctor
- Otc - Stop Use
- Otc - Keep Out Of Reach Of Children
- Directions
- Other Information
- Inactive Ingredients
Other
Drug Facts
Active Ingredients (In Each Gram)
Bacitracin Zinc (400 units)
Neomycin Sulfate 5mg (3.5mg Neomycin)
Polymyxin B Sulfate (5000 units)
Purpose
First Aid Antibiotic
First Aid Antibiotic
First Aid Antibiotic
Uses
First aid to help prevent infection in minor cuts, scrapes, and burns
Warnings
For external use only
Do Not Use
- In the eyes or apply over large areas of the body
- If you are allergic to any of the ingredients
- Longer than 1 week unless directed by a doctor
Otc - Ask Doctor
- Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns
Otc - Stop Use
Stop use and ask a doctor if the condition persists or gets worse, a rash or other allergic reaction develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions
Clean the affected area. Apply a small amount (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.
Other Information
Store at room temperature
Inactive Ingredients
White Petrolatum
* Please review the disclaimer below.