FDA.reportPublic FDA data

Antibiotic Gel

Manufacturer
Rosemont Ventures, Inc. | Monarch PCM, LLC
Effective date
2022-09-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:53:44

Label at a glance#

ProductAntibiotic Gel
Active ingredientBACITRACIN ZINC
Label structure9 sections

Indications and uses

First aid to help prevent infection in: minor cuts scrapes burns

Dosage and administration

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

Storage and handling

Store at 20-25C (68-77F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 500 Units

Purpose

OTC - PURPOSE SECTION

Bacitracin Zinc 500 Units.....First Aid Antibiotic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in:

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • rash or other reaction develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Pomegranate Sterols, Olus (Vegetable) Oil, Allantoin

Other Information

STORAGE AND HANDLING SECTION

  • Store at 20-25C (68-77F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antibiotic Gel

First Aid Antibiotic

0.5 FL OZ (15mL)

Made with 95+% naturally derived ingredients*

11

22

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82960-01382960-013-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
POMEGRANATE56687D1Z4DIACT
BACITRACIN ZINC89Y4M234ESACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d9a506c-7de8-a5f6-e063-6394a90a2f04e8bfa89c-f871-d207-e053-2995a90a4a3d2023-12-28WarningsExact identifier
spl set id: e8bfa89c-f871-d207-e053-2995a90a4a3d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.