NDC 21130-409 Signature Care Triple Antibiotic
Bacitracin Zinc, Neomycin, Polymyxin B
NDC Product Code 21130-409
Proprietary Name: Signature Care 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, Polymyxin B 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
- 21130 - Safeway
- 21130-409 - Signature Care Triple Antibiotic
NDC 21130-409-58
Package Description: 1 TUBE in 1 CARTON > 14 g in 1 TUBE
NDC 21130-409-64
Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE
NDC Product Information
Signature Care Triple Antibiotic with NDC 21130-409 is a a human over the counter drug product labeled by Safeway. The generic name of Signature Care Triple Antibiotic is bacitracin zinc, neomycin, polymyxin b. The product's dosage form is ointment and is administered via topical form.
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.
Signature Care 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)
- COCOA BUTTER (UNII: 512OYT1CRR)
- COTTONSEED OIL (UNII: H3E878020N)
- OLIVE OIL (UNII: 6UYK2W1W1E)
- SODIUM PYRUVATE (UNII: POD38AIF08)
- .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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: Safeway
Labeler Code: 21130
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: 10-14-2015 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’.
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Information for Patients
Neomycin, Polymyxin, and Bacitracin Topical
Neomycin, Polymyxin, and Bacitracin Topical is pronounced as (nee oh mye' sin) (pol i mix' in) (bass i tray' sin)
Why is neomycin, polymyxin, and bacitracin topical medication prescribed?
Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and b...
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Signature Care Triple Antibiotic Product Label Images
Signature Care 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)
- Purpose
- Uses
- Warnings
- Do Not Use
- Ask A Doctor Before Use If You Have
- Stop Use And Ask A Doctor If
- Keep Out Of Reach Of Children.
- Directions
- Other Information
- Inactive Ingredients
Active Ingredients (In Each Gram)
Bacitracin zinc equivalent to 400 units bacitracinNeomycin sulfate equivalent to 3.5 mg of neomycin basePolymyxin B 5,000 units as polymyxin B sulfate
Purpose
First aid antibiotic
Uses
- First aid to help prevent infection in minor: •cuts •scrapes •burns
Warnings
For external use only.
Do Not Use
- •if you are allergic to any of the ingredients •in the eyes •over large areas of the body
Ask A Doctor Before Use If You Have
- •deep or puncture wounds •animal bites •serious burns
Stop Use And Ask A Doctor If
- •you need to use longer than 1 week •condition persists or gets worse •rash or other allergic reaction develops
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- •clean the affected area •apply a small amount of this product (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 20-25°C (68-77°F)
Inactive Ingredients
Cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum
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