FDA.reportPublic FDA data

Tripleantibioticapainscaritch

Manufacturer
Trifecta Pharmaceutical USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:47:38

Label at a glance#

ProductTripleantibioticapainscaritch
Active ingredientPOLYMYXIN B SULFATE, BACITRACIN, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE
Label structure19 sections

Indications and uses

Helps prevent infection in and temporarily relieves pain due to minor cuts, scrapes and burns.

Dosage and administration

Adults and children 2 years and older: 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 Children under 2 years: ask a doctor

Storage and handling

To Open: Unscrew cap, pull tab to remove foil seal Store at 20° to 25°C (68° to 77°F) See carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin 500 Units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Neomycin 3.5mg

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Polymyxin B 10,000 Units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCL 10mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever

Uses

INDICATIONS & USAGE SECTION

Helps prevent infection in and temporarily relieves pain due to minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external use only. Do not use:

  • If you are allergic to any of the ingredients
  • in or near the eyes
  • on large areas of the body

Ask a Doctor before Use

OTC - ASK DOCTOR SECTION

Ask Doctor before use if you have:

  • Deep or puncture wouns
  • Animal bites
  • Serious burns

Stop Use and ask a Doctor if:

OTC - STOP USE SECTION

  • Condition persists or gets worse
  • Symptoms last for more than 7 days or clear up and come back within a few days
  • A rash or other allergic reaction develops

When using this product

OTC - WHEN USING SECTION

Do not use longer than 1 week

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

Adults and children 2 years and older:

  • 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

Children under 2 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • To Open: Unscrew cap, pull tab to remove foil seal
  • Store at 20° to 25°C (68° to 77°F)
  • See carton or tube crimp for lot number and expiration date

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Cocoa Butter, Levant Cottonseed Oil, Olive Oil, Petrolatum, Sodium pyruvate, vitamin E

Questions?

OTC - QUESTIONS SECTION

Call 1-888-296-9067 Weekdays 9AM - 4PM EST

DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

500 Volvo Parkway, Chesapeake, VA. 23320

NOT SATISFIED?

Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin® Plus Pain Relief.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

family wellness pain itch scar 1ozfamily wellness pain itch scar 1oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN4
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD4
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY4

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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-045-01Tripleantibioticapainscaritch28.4 g in 1 TUBEOINTMENT28.44
69396-045-01Tripleantibioticapainscaritch1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-045TRIPLEANTIBIOTICAPAINSCARITCH (FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCL) OINTMENT [TRIFECTA PHARMACEUTICAL USA LLC]4Current NDC, Legacy NDC, 2 package rows20241222_935106c6-8a9e-07fa-e053-2a95a90a2484.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-04569396-045-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PYRUVATEPOD38AIF08IACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
POLYMYXIN B SULFATE19371312D4ACTIM
OLIVE OIL6UYK2W1W1EIACT
PETROLATUM4T6H12BN9UIACT
BACITRACIN58H6RWO52IACTIB
NEOMYCIN SULFATE057Y626693ACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
LEVANT COTTONSEED OILN5CFT140R8IACT
COCOA BUTTER512OYT1CRRIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982f41ea6bd6efb…

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
TripleantibioticapainscaritchFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCLTrifecta Pharmaceutical USA LLC935106c6-8a9e-07fa-e053-2a95a90a24842024-12-20WarningsExact identifier
ndc (package): 69396-045-01
ndc (product): 69396-045
ndc11 (package): 69396004501
spl id: 29b3ad9e-827e-f9c8-e063-6294a90a598e
spl set id: 935106c6-8a9e-07fa-e053-2a95a90a2484

Reported adverse events (FAERS/openFDA)#

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