FDA.reportPublic FDA data

Double Antibiotic

Manufacturer
A-S Medication Solutions
Effective date
2017-10-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 01:11:37

Label at a glance#

ProductDouble Antibiotic
Active ingredientBACITRACIN ZINC, POLYMYXIN B SULFATE
Label structure5 sections

Label contents#

Full prescribing information#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (equal to 500 bacitracin units)

Polymyxin B Sulfate (equal to 10,000 polymyxin B units)

Purpose

OTC - PURPOSE SECTION

Antibiotic

Antibiotic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burn

For external use only

SPL UNCLASSIFIED SECTION

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 in case of deep or puncture wounds, animal bites or serious burns

OTC - WHEN USING SECTION

When using this product do not use longer than 1 week unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • the condition persists or gets worse
  • if a rash or other allergic 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.

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

Other information store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredient white petrolatum

SPL UNCLASSIFIED SECTION

Questions or comments? call toll free 1-800-645-9833

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0325

NDC: 50090-0325-0 14.17 g in a TUBE

Bacitracin Zinc and Polymyxin B Sulfate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0021-09EA - Each0168-002153fd61b0-6893-4b1f-ae10-61d1bb422c9812012-07-24
0168-0021-31GM - Gram0168-002176f30bd5-b2a6-474d-a05e-824eda21c0e112012-07-24
0168-0021-35GM - Gram0168-0021ff516210-b74f-4ed5-8d43-a37d6e6164f112012-07-24

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-032550090-0325-0
0168-0021

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
BACITRACIN ZINC89Y4M234ESACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
petrolatum4T6H12BN9UIACT

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
e9c5aada-7aba-4f24-9049-71f3182b997a395ba2b4-ed29-49c7-a181-4eaca4e60d4a2017-10-04WarningsExact identifier
spl id: e9c5aada-7aba-4f24-9049-71f3182b997a
spl set id: 395ba2b4-ed29-49c7-a181-4eaca4e60d4a

Reported adverse events (FAERS/openFDA)#

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