Bacitracin (topical)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Bacitracin (topical) is a antibiotic that is FDA approved for the treatment of deep or puncture wounds, animal bites and serious burns. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Ask a doctor before use:
- in case of deep or puncture wounds
- animal bites
- serious burns
PURPOSE
- First aid to help prevent infection in:
- Minor cuts
- scrapes
- burns
Dosing Information
- clean the affected areas
- apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
- may be covered with a sterile bandage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Bacitracin (topical) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Bacitracin (topical) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Bacitracin (topical) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Bacitracin (topical) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Bacitracin (topical) in pediatric patients.
Contraindications
There is limited information regarding Bacitracin (topical) Contraindications in the drug label.
Warnings
- For external use only
Stop use and ask a doctor if:
- The condition persists or gets worse, or if a rash or other allergic reaction develops.
Do not use:
- If you are allergic to any of the ingredients
- in the eyes
- over large areas of the body
- longer than 1 week unless directed by a doctor
Keep out of reach of children
- if swallowed, get medical help or contact a Poison Control Center right away
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Bacitracin (topical) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Bacitracin (topical) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Bacitracin (topical) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Bacitracin (topical) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bacitracin (topical) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Bacitracin (topical) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Bacitracin (topical) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Bacitracin (topical) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Bacitracin (topical) in geriatric settings.
Gender
There is no FDA guidance on the use of Bacitracin (topical) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Bacitracin (topical) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Bacitracin (topical) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Bacitracin (topical) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Bacitracin (topical) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Bacitracin (topical) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Bacitracin (topical) Administration in the drug label.
Monitoring
There is limited information regarding Bacitracin (topical) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Bacitracin (topical) and IV administrations.
Overdosage
There is limited information regarding Bacitracin (topical) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Bacitracin (topical) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Bacitracin (topical) Mechanism of Action in the drug label.
Structure
There is limited information regarding Bacitracin (topical) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Bacitracin (topical) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Bacitracin (topical) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Bacitracin (topical) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Bacitracin (topical) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Bacitracin (topical) How Supplied in the drug label.
Storage
- Store at controlled room temperature 15°-30° C (59°-86° F)
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Bacitracin (topical) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Bacitracin (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Bacitracin (topical) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Bacitracin (topical) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.