Budpak Bacitracin
FDA Label NDC 27293-035

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Budpak Inc. for the product Budpak Bacitracin (NDC 27293-035). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - 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

Otc - Active Ingredient

Active Ingredient (each gram contains):

Bacitracin Zinc 500 units

Otc - Purpose

Purpose:

First aid antibiotic

Indications & Usage

Uses:

First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

Warnings:

For external use only.

Otc - Do Not Use

Do not use:

In the eyes, if you are allergic to any of the ingredients, over large areas of the body, longer than 1 week unless directed by a doctor.

Otc - Ask Doctor

Ask a doctor before use:

In case of deep or puncture wounds, animal bites or serious burns

Otc - Stop Use

Stop use and ask a doctor if:

Condition persists or gets worse. 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 immediately.

Dosage & Administration

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.

Other

Other Information:

Store at 15°C to 25°C (59°F to 77°F). Lot No. & Exp. Date: See  box or crimp of tube.

Inactive Ingredient

Inactive Ingredients:

Hard Paraffin, Liquid Paraffin, White Soft Paraffin .

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

Budpak Bacitracin Ointment

First Aid Antibiotic with Zinc

NET WT .5 OZ (14 g)

Carton (Bacitracin Ointment)

Carton (Bacitracin Ointment)

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