FDA.reportPublic FDA data

Triple Antibiotic

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | Fougera Pharmaceuticals Inc.
Effective date
2012-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:44:48

Label at a glance#

ProductTriple Antibiotic
Active ingredientBacitracin Zinc, NEOMYCIN SULFATE, Polymyxin B Sulfate
Label structure8 sections

Label contents#

Full prescribing information#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

  • Neomycin Sulfate (5 mg equivalent to 3.5 mg neomycin base)
  • Polymyxin B Sulfate (equal to 5,000 polymyxin B units)
  • Bacitracin Zinc (equal to 400 bacitracin units)

Purpose

OTC - PURPOSE SECTION

Antibiotic
Antibiotic
Antibiotic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

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/PHARMACIST SECTION

Ask a doctor before use in case of deep or puncture wounds, animal bites or serous 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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
  • store at room temperature
  • see crimp of tube for Lot No. and Exp. date

INACTIVE INGREDIENT SECTION

Inactive ingredient white petrolatum

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0012-35

Triple Antibiotic Ointment
(Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0012-35

Fougera ®

Triple
Antibiotic Ointment
(Neomycin and Polymyxin B
Sulfates and Bacitracin Zinc
Ointment USP)

The economical way to help treat
minor cuts, scrapes, and burns.

First Aid Antibiotic

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CARTON
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0012-09

Fougera®

First Aid Antibiotic NET WT 0.9 g (1/32 Oz)


Triple Antibiotic Ointment
(Neomycin and Polymyxin B Sulfates
and Bacitracin Zinc Ointment USP)

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0012-09

Fougera ®

Triple
Antibiotic Ointment
(Neomycin and Polymyxin B Sulfates
and Bacitracin Zinc Ointment USP)

First Aid Antibiotic

This product available in tubes at pharmacy.

1 GROSS
NET WT 0.9 g (1/32 Oz) FOILPACS®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON - NET WT. 0.9 g (1/32 Oz) FOILPACS
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON - NET WT. 0.9 g (1/32 Oz) FOILPACS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0012-09EA - Each0168-0012f955a9b2-cb31-4572-a5ec-c455dd57c71b12012-07-24
0168-0012-31GM - Gram0168-0012744c935d-272c-436f-8e28-39a21fb01c4312012-07-24
0168-0012-35GM - Gram0168-001271a23c05-c781-467e-aca8-9c0a572a572412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ES2
NEOMYCIN SULFATEACTIVE INGREDIENT057Y6266932
Polymyxin B SulfateACTIVE INGREDIENT19371312D42
BACITRACINACTIVE MOIETY58H6RWO52I2
NEOMYCINACTIVE MOIETYI16QD7X2972
Polymyxin BACTIVE MOIETYJ2VZ07J96K2
petrolatumINACTIVE INGREDIENT4T6H12BN9U2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0168-00120168-0012-35, 0168-0012-31, 0168-0012-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Bacitracin Zinc89Y4M234ESACTIB
NEOMYCIN SULFATE057Y626693ACTIM
Polymyxin B Sulfate19371312D4ACTIB
petrolatum4T6H12BN9UIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates

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
17785628-26c0-4498-aba8-c121fafb36d4b60b7ea1-7fda-4417-ac43-eb5129136b952012-10-22WarningsExact identifier
spl id: 17785628-26c0-4498-aba8-c121fafb36d4
spl set id: b60b7ea1-7fda-4417-ac43-eb5129136b95

Reported adverse events (FAERS/openFDA)#

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