FDA.reportPublic FDA data

Triple antibiotic and pain relief cream

Manufacturer
Trifecta Pharmaceutical USA LLC
Effective date
2019-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:02:12

Label at a glance#

ProductFamily Wellness Plus Pain Relief
Active ingredientNEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE, POLYMYXIN B SULFATE
Label structure16 sections

Indications and uses

First Aid to help prevent infection in minor: Cuts Scrapes Burns

Dosage and administration

Clean the affected area and dry thoroughly 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

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

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

External Analgesic

Uses

INDICATIONS & USAGE SECTION

First Aid to help prevent infection in minor:

  • Cuts
  • Scrapes
  • Burns

Warnings

WARNINGS SECTION

For external use only. Do not use:

  • In eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients

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
  • You need to use longer than 1 week
  • 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 and dry thoroughly
  • 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

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

Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl Sterate, Levelling Agent O, Light Mineral Oil, Petrolatum, Purified Water, Sodium Dodecyl Sulfate.

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.

MADE IN CHINA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

triple antibiotic plus pain 3triple antibiotic plus pain 3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN4
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD4
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY4
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY4
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69396-043-012021-01-29C16284748780-1ba0f9c33-169e-a910-e053-dadaa90a0b85Triple Antibiotic + Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-043-01Family Wellness Plus Pain Relief28.4 g in 1 TUBECREAM28.44
69396-043-01Family Wellness Plus Pain Relief1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-043FAMILY WELLNESS PLUS PAIN RELIEF (FAMILY WELLNESS NEOMYCIN,POLYMYXINB,PRAMOXINEHCL) CREAM [TRIFECTA PHARMACEUTICAL USA LLC]4Legacy NDC, 2 package rows20191221_9350688e-f456-d9e5-e053-2995a90aa8bb.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-04369396-043-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURYL ALCOHOL178A96NLP2IACT
LIGHT MINERAL OILN6K5787QVPIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
PETROLATUM4T6H12BN9UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
NEOMYCIN SULFATE057Y626693ACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
POLYMYXIN B SULFATE19371312D4ACTIM
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
WATER059QF0KO0RIACT
ETHYLPARABEN14255EXE39IACT

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
98fac7f9-0d41-8da5-e053-2995a90a83909350688e-f456-d9e5-e053-2995a90aa8bb2019-12-05WarningsExact identifier
spl id: 98fac7f9-0d41-8da5-e053-2995a90a8390
spl set id: 9350688e-f456-d9e5-e053-2995a90aa8bb

Reported adverse events (FAERS/openFDA)#

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