FDA.reportPublic FDA data

Quality Choice Multi-Action Ointment

Manufacturer
Chain Drug Marketing Association Inc. | Trifecta Pharmaceuticals USA LLC
Effective date
2023-05-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:55:04

Label at a glance#

ProductMulti Action
Active ingredientPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE
Label structure20 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 Zinc 500 Units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Neomycin Sulfate 3.5mg

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Polymyxin B Sulfate 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 wounds
  • Animal bites
  • Serious burns

Stop Use and ask a Doctor if:

OTC - STOP USE SECTION

  • Condition lasts 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 1-800-935-2362

Other Information

SPL UNCLASSIFIED SECTION

Distributed By

CDMA Inc.

Novi, MI 48375

www.qualitychoice.com

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

qc-triple-antibiotic-1oz-CDER 4qc-triple-antibiotic-1oz-CDER 4

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 OintmentPSN2
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD2
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-912-012025-01-30C16284748780-12cef2736-b181-d83d-e063-dadaa90ab31fQuality Choice Multi-Action Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-912-01Multi Action1 in 1 BOXOINTMENT12
63868-912-01Multi Action28.3 g in 1 TUBEOINTMENT28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-912MULTI ACTION (BACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC.]2Legacy NDC, 2 package rows20230525_eac8e7a8-4524-7377-e053-2a95a90a9a63.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-912-01GM - Gram63868-9120aab0abd-99f4-4f7f-85fb-15cf685cddd112022-12-07

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
63868-91263868-912-01

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
OLIVE OIL6UYK2W1W1EIACT
PETROLATUM4T6H12BN9UIACT
LEVANT COTTONSEED OILN5CFT140R8IACT
COCOA BUTTER512OYT1CRRIACT
POLYMYXIN B SULFATE19371312D4ACTIM
BACITRACIN ZINC89Y4M234ESACTIB
NEOMYCIN SULFATE057Y626693ACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

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
fc61822a-3fba-343c-e053-6294a90af72ceac8e7a8-4524-7377-e053-2a95a90a9a632023-05-23WarningsExact identifier
spl id: fc61822a-3fba-343c-e053-6294a90af72c
spl set id: eac8e7a8-4524-7377-e053-2a95a90a9a63

Reported adverse events (FAERS/openFDA)#

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