FDA.reportPublic FDA data

Quality Choice Triple Antibiotic Ointment Plus Pain Relief

Manufacturer
Chain Drug Marketing Association Inc. | Trifecta Pharmaceuticals USA LLC.
Effective date
2023-05-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:02

Label at a glance#

ProductTriple Antibiotic Plus Pain Relief
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Label structure12 sections

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.

Label contents#

Full prescribing information#

Active ingredients (each gram contains)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc 400 units



Neomycin sulfate 3.5 mg



Polymyxin B sulfate 5,000 units

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCL

Purpose

OTC - PURPOSE SECTION

External Analgesic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

WARNINGS SECTION

Warnings For external use only.

Do not use ● in the eyes ● 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 ● serious burns.

Stop use and ask a doctor if ● condition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops

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.

INACTIVE INGREDIENT SECTION

Inactive ingredientMineral Oil,Petrolatum

Other information

SPL UNCLASSIFIED 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.

Other Information

SPL UNCLASSIFIED SECTION

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

questions: 800-935-2362

Product of PRC

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

qc triple antibiotic plus pain 1ozqc triple antibiotic plus pain 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 OintmentPSN3
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD3
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY3

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
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
63868-576-012025-01-30C16284748780-1f386c64a-32a3-0266-e053-dadaa90a7c1aQuality Choice Triple Antibiotic Ointment Plus Pain Relief
63868-576-012023-05-23C16284748780-1f386c64a-32a3-0266-e053-dadaa90a7c1aQuality Choice Triple Antibiotic Ointment Plus Pain Relief
63868-576-012023-01-30C16284748780-1f386c64a-32a3-0266-e053-dadaa90a7c1aQuality Choice Triple Antibiotic Ointment Plus Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-576-01Triple Antibiotic Plus Pain Relief1 in 1 BOXOINTMENT13
63868-576-01Triple Antibiotic Plus Pain Relief28.3 g in 1 TUBEOINTMENT28.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-576TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC.]3Legacy NDC, 2 package rows20230524_a7d5e12e-c6bf-44b0-e053-2995a90a1ce2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-576-01GM - Gram63868-576e1d04bb2-4d70-4e34-b26c-9f4203f930a912022-10-06

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-57663868-576-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
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
fc5f0913-8738-35cb-e053-6294a90accada7d5e12e-c6bf-44b0-e053-2995a90a1ce22023-05-23WarningsExact identifier
spl id: fc5f0913-8738-35cb-e053-6294a90accad
spl set id: a7d5e12e-c6bf-44b0-e053-2995a90a1ce2

Reported adverse events (FAERS/openFDA)#

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