Single Antibiotic Ointment
FDA Label NDC 61010-4404

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Single Antibiotic (NDC 61010-4404). 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 other, active ingredient, purpose, uses, warnings, do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Otc - Ask Doctor

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel – Tube Label

Other

Drug Facts

Active Ingredient

Bacitracin Zinc (500 units in each gram)

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 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

Otc - Ask Doctor

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Otc - Stop Use

Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops

Otc - Keep Out Of Reach Of Children

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 (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