FDA.reportPublic FDA data

REPARA (Triple Antibiotic), ointment

Manufacturer
PSS WORLD MEDICAL, INC. | Zhejiang Medicare Pharmaceutical Co., Ltd.
Effective date
2013-06-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:35:51

Label at a glance#

ProductRepara Triple Antibiotic
Active ingredientBACITRACIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure10 sections

Indications and uses

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

Dosage and administration

clean the affected area apply a small amount of the 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 temperature between 15°C - 30°C (59°F- 86°F).

Label contents#

Full prescribing information#

Active Igredients:

OTC - ACTIVE INGREDIENT SECTION

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5,000 units

Purpose:

OTC - PURPOSE SECTION

Antibiotic


Inactive Ingredients:

INACTIVE INGREDIENT SECTION

White petrolatum

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.

Uses:

INDICATIONS & USAGE SECTION

First aid antibiotic to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings:

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

Do not use

• in the eyes or apply over large areas of the body

• if you are allergic to any of the ingredients

Ask a doctor before use if you have

• deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

• the condition worsen

• symptons last more than 7 days or clear up and occur again within a few days

Directions:

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of the 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

Comments or Questions?

OTC - QUESTIONS SECTION

800-777-4908

Manufactured for PSS World Medical, Inc.
4345 Southpoint Blvd., Jacksonville, FL 32216
Made in China

Storage Information

STORAGE AND HANDLING SECTION

Store at temperature between 15°C - 30°C (59°F- 86°F).

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Repara® Advanced Skincare

NDC 68345-820-26

Triple Antibiotic Ointment Bacitracin•Neomycin•Polymyxin B

NET WT. 28g. Reorder #892

892_Each

892_Each892_Each

892_EachBox

892_EachBox892_EachBox

892_Box

892_Box892_Box

892_Case

892_Case892_Case

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN2
1427298REPARA Triple Antibiotic 400 UNT / 3.5 MG / 5000 UNT per GM Topical OintmentPSN2
1427298bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment [Repara Triple Antibiotic]SBD2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY2
1427298Repara Triple Antibiotic (bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT) per GM Topical OintmentSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68345-820-222019-11-27C16284748780-19855d018-d8cb-cd31-e053-dbdaa90ab51aREPARA (Triple Antibiotic), ointment
68345-820-262019-11-27C16284748780-19855d018-d8cb-cd31-e053-dbdaa90ab51aREPARA (Triple Antibiotic), ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68345-820-22Repara Triple Antibiotic12 in 1 CASEOINTMENT122
68345-820-22Repara Triple Antibiotic144 in 1 BOXOINTMENT1442
68345-820-26Repara Triple Antibiotic12 in 1 BOXOINTMENT122
68345-820-26Repara Triple Antibiotic12 in 1 CASEOINTMENT122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68345-820REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]2Legacy NDC, 4 package rows20130620_f169f613-91b3-47f2-aac1-49cd1d7f6d8a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52I2
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 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68345-82068345-820-22, 68345-820-26

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
BACITRACIN58H6RWO52IACTIB
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
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
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact 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
9a511d5b-c719-4a2e-81fb-0cc6c55ad8a6f169f613-91b3-47f2-aac1-49cd1d7f6d8a2013-06-19WarningsExact identifier
spl id: 9a511d5b-c719-4a2e-81fb-0cc6c55ad8a6
spl set id: f169f613-91b3-47f2-aac1-49cd1d7f6d8a

Reported adverse events (FAERS/openFDA)#

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