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Bacitracin - Medication Information

Product NDC Code 67777-116
Drug Name

Bacitracin

Type Generic
Pharm Class Decreased Cell Wall Synthesis & Repair [PE]
Active Ingredients
Bacitracin 500 [usp'u]/1000mg
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 1648110
Application Number part333B
Labeler Name Dynarex Corporation
Packages
Package NDC Code Description
67777-116-10 1728 box in 1 case (67777-116-10) / 144 packet in 1 box (67777-116-11) / 900 mg in 1 packet
67777-116-20 72 tube in 1 case (67777-116-20) / 14000 mg in 1 tube (67777-116-21)
67777-116-30 72 box in 1 case (67777-116-30) / 1 tube in 1 box (67777-116-31) / 28400 mg in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Bacitracin (500 units in each gram)

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. 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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Hard Paraffin, Liquid Paraffin, White Soft Paraffin

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.
Use First aid to help prevent infection in minor cuts, scrapes, and 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 Bacitracin WHITE PETROLATUM PARAFFIN MINERAL OIL BACITRACIN 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.
Label 1161 Bacitracin Ointment 1161 BX MASTER Label 1162 Bacitracin Ointment 1162 BX MASTER Label 1163 Bacitracin Ointment 1163 BX MASTER

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

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 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

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

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store at room temperature

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 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 Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns If swallowed, get medical help or contact a Poison Control Center right away.

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