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astonea
Bacitracin Zinc · Ointment
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Decreased Cell Wall Synthesis & Repair [PE] | PE | All 41 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 20240625). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses ■ helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect from the drying effects of wind and cold weather ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash ■ with each diaper change, espicially at bedtime when exposure to wet diapers may be prolonged
Purpose
openFDA Drug LabelingPurpose First Aid Antibiotic
Dosage and Administration
openFDA Drug LabelingDirections ■ 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
Warnings
openFDA Drug LabelingWarnings For external use only
Do Not Use
openFDA Drug LabelingDo not use ■ Not for opthalmic use Do not use ■ in the eyes ■ if you are allergic to any of the ingredients, due to possibility of anaphylactic shock ■ over large areas of the body ■ longer than 1 week unless directed by a doctor
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use in case of ■ deep or puncture wounds ■ animal bites ■ serious burns
Stop Use
openFDA Drug LabelingStop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days
Active Ingredient
openFDA Drug LabelingActive Ingredient (in each gram) Bacitracin Zinc (equal to 500 bacitracin units)
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: BACITRACIN ZINC. 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 |
|---|---|---|---|---|
| 77338-303-52 | 77338-303 | ASTONEA LABS PRIVATE LIMITED | .9 g in 1 PACKET (77338-303-52) | May 2, 2022 |
| 77338-303-53 | 77338-303 | ASTONEA LABS PRIVATE LIMITED | 28.3 g in 1 TUBE (77338-303-53) | May 2, 2022 |
| 77338-307-02 | 77338-307 | ASTONEA LABS PRIVATE LIMITED | 5 g in 1 PACKET (77338-307-02) | May 23, 2013 |
| 77338-307-03 | 77338-307 | ASTONEA LABS PRIVATE LIMITED | 28.3 g in 1 TUBE (77338-307-03) | May 23, 2013 |
| 77338-307-04 | 77338-307 | ASTONEA LABS PRIVATE LIMITED | 113 g in 1 TUBE (77338-307-04) | May 23, 2013 |
| 77338-307-05 | 77338-307 | ASTONEA LABS PRIVATE LIMITED | 425 g in 1 JAR (77338-307-05) | May 23, 2013 |
| 77338-303 | 77338-303 | ASTONEA LABS PRIVATE LIMITED | — | May 2, 2022 |
| 77338-307 | 77338-307 | ASTONEA LABS PRIVATE LIMITED | — | May 23, 2013 |
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.