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Bacitracin Zinc · Ointment
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Bacitracin Zinc | 400 [iU]/g | 204602 | View |
| Bacitracin Zinc | 500 [iU]/g | 204602 | View |
| Neomycin Sulfate | 3.5 mg/g | 204602 | View |
| Polymyxin B Sulfate | 10000 [iU]/g | 204602 | View |
| Polymyxin B Sulfate | 5000 [iU]/g | 204602 | View |
| Pramoxine Hydrochloride | 10 mg/g | 1234532 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Aminoglycoside Antibacterial [EPC] | EPC | All 66 members |
| Aminoglycosides [CS] | CS | All 66 members |
| Decreased Cell Wall Synthesis & Repair [PE] | PE | All 41 members |
| Polymyxin-class Antibacterial [EPC] | EPC | All 55 members |
| Polymyxins [CS] | CS | All 55 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 000004-004 | PAREDRINE | SOLUTION/DROPS | HYDROXYAMPHETAMINE HYDROBROMIDE | Discontinued | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 11 | Labeling | Approved | May 26, 1987 | — |
| Supplement | 10 | Labeling | Approved | May 8, 1980 | — |
| Original application | 1 | Approved | July 16, 1969 | Unknown |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250715). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses first aid to help prevent infection and for the temporary relief of pain or discomfort in minor: cuts scrapes burns
Purpose
openFDA Drug LabelingActive ingredients (each gram contains) Purpose Bacitracin zinc 500 units First aid antibiotic Neomycin sulfate 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine hydrochloride 10 mg External analgesic
Dosage and Administration
openFDA Drug LabelingDirections Adults and children 2 years of age and older: clean the affected area and dry thoroughly 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 Children under 2 years of age: ask a doctor
Warnings
openFDA Drug LabelingWarnings For external use only. Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition persists or gets worse you need to use longer than 1 week symptoms persist for more than 1 week, or clear up and occur again within a few days a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
openFDA Drug LabelingDo not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have deep or puncture wounds animal bites serious burns
Stop Use
openFDA Drug LabelingStop use and ask a doctor if condition persists or gets worse you need to use longer than 1 week symptoms persist for more than 1 week, or clear up and occur again within a few days a rash or other allergic reaction develops
Active Ingredient
openFDA Drug LabelingActive ingredients (each gram contains) Purpose Bacitracin zinc 500 units First aid antibiotic Neomycin sulfate 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine hydrochloride 10 mg External analgesic
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: POLYMYXIN B SULFATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 51143-016-02 | 51143-016 | The Great Atlantic & Pacific Tea Company | 1 TUBE in 1 CARTON (51143-016-02) / 28.4 g in 1 TUBE | December 14, 1995 |
| 51143-027-02 | 51143-027 | The Great Atlantic & Pacific Tea Company | 1 TUBE in 1 CARTON (51143-027-02) / 28.4 g in 1 TUBE | March 31, 2012 |
| 51143-075-02 | 51143-075 | The Great Atlantic & Pacific Tea Company | 1 TUBE in 1 CARTON (51143-075-02) / 28.4 g in 1 TUBE | May 11, 2006 |
| 51143-016 | 51143-016 | The Great Atlantic & Pacific Tea Company | — | December 14, 1995 |
| 51143-027 | 51143-027 | The Great Atlantic & Pacific Tea Company | — | March 31, 2012 |
| 51143-075 | 51143-075 | The Great Atlantic & Pacific Tea Company | — | May 11, 2006 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.