Sionbiotext Triple Antibiotic Ointment
FDA Label NDC 68786-400

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 Sionbiotext Triple Antibiotic (NDC 68786-400). 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, stop use and ask a doctor if, if pregnant or breast feeding, 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

→ Active Ingredient (in Each Gram)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast Feeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions

→ Package Label.principal Display Panel

Active Ingredient (In Each Gram)

Bacitracin Zinc (400 units)

Neomycin sulfate 5mg (equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate (500 units)

Purpose

First Aid Antibiotic

Uses

First aid to prevent infection in

minor cuts
scrapes
burns

Warnings

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 of the ingredients
longer than 1 week unless directed by a doctor
if the seal is torn or if the tube is damaged

Stop Use And Ask A Doctor If

if condition persists or gets worse
a rash or other allergic reaction develops

If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out Of Reach Of Children

If swalloed, 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) on the area 1 to 3 times daily
may be covered with a sterile bandage