Active Ingredient (In Each Gram)
Bacitracin zinc 500 units
Elixirbacishield Ointment
FDA Label NDC 84546-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elixir Healthcare Usa, Llc. for the product Elixirbacishield (NDC 84546-0002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each gram), purpose, uses, warnings, do not use, ask a doctor before use in case of, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
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
• if you are allergic to any of the ingredients
• over large areas of the body or for longer than 1 week unless directed by a doctor
Ask A Doctor Before Use In Case Of
• deep or puncture wounds
• animal bites
• serious burns
Stop Use And Ask A Doctor If
• condition persists or gets worse
• a 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.
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) 1 to 3 times daily.
• May be covered with a sterile bandage.
Inactive Ingredients
hard paraffin, mineral oil, lanolin, white soft paraffin.
Other Information
Store at 15°–30°C (59°–86°F). Avoid excessive heat and humidity.
Principal Display Panel
*Compare to the active ingredient in ACTAVIS BACIRACIN ZINC OINTMENT USP
NDC: 84546-0002-01
Bacitracin Zinc Ointment USP
First AID ANTIBIOTIC
Elixir
Net Wt. 1 oz, (28.3 gm)
Help prevent infection in minor cuts, scrapes & burns
Reorder No: MRP-XXXX
Elixir
Bacitracin Zinc Ointment USP (0.9Gram)
First AID ANTIBIOTIC
Help prevent infection in minor cuts, scrapes & burns
Net Wt. 0.9G, (500 Packets)
Reorder No: MRP-XXXX
* Please review the disclaimer below.
