Active Ingredient
Bacitracin Zinc (equal to 500 Bacitracin units)
Claravie Ointment
FDA Label NDC 61554-310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gentell Llc for the product Claravie (NDC 61554-310). 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, purpose, uses, directions, warnings, do not use, when using, ask a doctor before use in case of, 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
- Burns
Directions
- Clean the affected area.
- Apply a small amount of the product (about the size of the tip of the finger) to the affected area 1 to 3 times daily.
- May be covered with a sterile bandage.
Warnings
For external use only
Do Not Use
In the eyes; if you are allergic to any ingredients due to possibility of anaphylactic shock.
When Using
Over large areas of the body; 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 Consult A Doctor If
- Condition persists or worsens
- A rash or other allergic reaction develops
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Other Information
- Store at 59°F–86°F (15°C–30°C).
- Avoid excessive heat and humidity.
- Tamper evident.
- Do not use if tube is cut, torn, or opened.
Inactive Ingredients
Hard Paraffin
Lanolin
Mineral Oil
White Soft Paraffin
Otc - Questions
1-800-840-9041
www.gentell.com
Dosage & Administration
- Apply a small amount of the product (about the size of the tip of the finger) to the affected area 1 to 3 times daily.
Bacitracin Zinc Ointment
Bacitracin Zinc Ointment Label:
* Please review the disclaimer below.
