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Bacitracin zinc - Medication Information

Product NDC Code 69396-104
Drug Name

Bacitracin zinc

Type Generic
Pharm Class Decreased Cell Wall Synthesis & Repair [PE]
Active Ingredients
Bacitracin zinc 500 [usp'u]/g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 1366116
Application Number part333B
Labeler Name Trifecta Pharmaceuticals USA LLC
Packages
Package NDC Code Description
69396-104-09 144 packet in 1 carton (69396-104-09) / .9 g in 1 packet
69396-104-25 25 packet in 1 carton (69396-104-25) / .9 g in 1 packet
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Bacitracin Zinc 500 Units

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Clean the affected area and dry thoroughly. Apply a small amount of the 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Mineral oil, white petrolatum

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses First Aid to help prevent infection in minor cuts scrapes burns

Purpose

Information about the drug product’s indications for use.
Purpose First Aid Antibiotic

Spl product data elements

Usually a list of ingredients in a drug product.
Bacitracin Zinc Bacitracin Zinc PETROLATUM MINERAL OIL BACITRACIN ZINC BACITRACIN

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Packaging 1013SL GLOBE BACITRACIN OINTMENT 0.9G 144CT 060523 CDER_ 1014SL GLOBE BACITRACIN OINTMENT 0.9G 25CT 121422 CDER

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other Information Distributed By: Trifecta Pharmaceuticals USA® Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do Not Use in eyes over large areas of the body if you are allergic to any of the ingredients

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center Immediately.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions Call 1-888-296-9067 Fax: 1-888-878-3609 Online: www.trifecta-pharma.com Reorder No. 1013SL

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop Use and Ask Doctor if Before use in case of deep puncture wounds, animal bites or serious burns The condition persists or gets worse A rash or allergic reaction develops

Storage and handling

Information about safe storage and handling of the drug product.
Storage Information Store at room temperature 15° to 25°C (59° to 77°F).

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For External Use Only.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API