Sion Biotext Bacitracin Zinc Ointment
FDA Label NDC 68786-500

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sion Biotext Medical Ltd for the product Sion Biotext Bacitracin Zinc (NDC 68786-500). 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 section, do not use, stop use and ask a doctor if, keep out of reach of children, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Gram)

→ Purpose

→ Uses

→ Warnings Section

→ Do Not Use

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ If Pregnant Or Breast Feeding

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions

→ Distributed By

→ Package Label.principal Display Panel

Active Ingredient (In Each Gram)

Bacitracin Zinc (500 units)

Purpose

First Aid Antibiotic

Uses

First aid to prevent infection in

minor cuts
scrapes
burns

Warnings Section

For external use only

Do Not Use

in the eyes
over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor
if you are allergic to any ingredient
longer than 1 week unless directed by a doctor
If seal is torn or if the tube is damaged

Stop Use And Ask A Doctor If

the 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 posion control center right away.

If Pregnant Or Breast Feeding

ask a health professional before use

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) an the area 1 to 3 times a day
- may be covered with a sterile bandage