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astonea

Bacitracin Zinc · Ointment

Over-the-counter M Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
astonea First Aid
Generic name
Bacitracin Zinc
Dosage form
Ointment
Route
Topical
Marketing category
OTC MONOGRAPH DRUG · OTC MONO
Labeler
ASTONEA LABS PRIVATE LIMITED
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
6
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Bacitracin Zinc 500 [USP'U]/g 204602 View
Petrolatum 76 g/100g 706820 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Ointment
Route of administration
Topical
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Cell Wall Synthesis & Repair [PE] PE All 41 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
000004
Application type
M
Approval date
July 16, 1969
Sponsor
PHARMICS
Products on application
1
Submissions recorded
3
Products approved under application 000004.
Product Trade name Form Strength Ingredient Status TE Flags
000004-004 PAREDRINE SOLUTION/DROPS HYDROXYAMPHETAMINE HYDROBROMIDE Discontinued —

Approval history

Source: Drugs@FDA
Most recent submissions on application 000004.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20240625 HUMAN OTC DRUG · 20240625

Indications and Usage

openFDA Drug Labeling

Uses ■ 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 First Aid Antibiotic

Dosage and Administration

openFDA Drug Labeling

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

Warnings For external use only

Do 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 Labeling

Ask a doctor before use in case of ■ deep or puncture wounds ■ animal bites ■ serious burns

Stop 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 Labeling

Active Ingredient (in each gram) Bacitracin Zinc (equal to 500 bacitracin units)

Adverse event reports

Source: openFDA FAERS
4,395
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.