Quality Choice Bacitracin Zinc Ointment

Manufacturer
Chain Drug Marketing Association Inc. | Trifecta Pharmaceuticals USA LLC
Effective date
2023-03-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:54:20

Label at a glance#

ProductBacitracin Zinc
Active ingredientBACITRACIN ZINC
Label structure12 sections

Indications and uses

First Aid to help prevent infection in minor cuts scrapes burns

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 500 Units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

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

OTC - DO NOT USE SECTION

  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Ask Doctor before Use

OTC - ASK DOCTOR SECTION

In care of deep puncture wounds, animal bites, or serious burns.

Stop Use and Ask Doctor if

OTC - STOP USE SECTION

  • The condition persists or gets worse
  • A rash or allergic reaction develops

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, mineral oil, 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 immediately.

Other Information

SPL UNCLASSIFIED SECTION

Store Between 15° to 25°C (59° to 77°F)

Lot No. and Exp. date: see box and tube crimp

Distributed By:

C.D.M.A, Inc. ©

43157 W 9 Mile Rd

Novi, MI. 48375

www.qualitychoice.com

1-800-935-2362

Product of PRC

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

qc bacitracin 1ozqc bacitracin 1oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN4
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD4
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-574-01Bacitracin Zinc1 in 1 BOXOINTMENT14
63868-574-01Bacitracin Zinc28.3 g in 1 TUBEOINTMENT28.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-574BACITRACIN ZINC OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC.]4Legacy NDC, 2 package rows20230303_a7d4d306-31e8-05b7-e053-2a95a90acee5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-574-01GM - Gram63868-5742a003002-6fb3-4630-a2f3-15e9757b721412022-10-06

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-57463868-574-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
f5edb048-977e-0a82-e053-2995a90af50da7d4d306-31e8-05b7-e053-2a95a90acee52023-03-02WarningsExact identifier
spl id: f5edb048-977e-0a82-e053-2995a90af50d
spl set id: a7d4d306-31e8-05b7-e053-2a95a90acee5

Reported adverse events (FAERS/openFDA)#

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