GenMed ZINC OXIDE Ointment USP with Blue Dye

Manufacturer
​BRANDS INTERNATIONAL
Effective date
2023-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:30

Label at a glance#

ProductZINC OXIDE
Active ingredientZINC OXIDE
Label structure10 sections

Dosage and administration

for diaper rash change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply ointment liberally with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged for poison ivy, oak, sumac apply ointment liberally as often as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (20% w/w)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Purpose

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • dries the oozing and weeping of poison ivy, poison oak, poison sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not use over large areas of the body

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

  • for diaper rash
  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • for poison ivy, oak, sumac
  • apply ointment liberally as often as needed

Other information

OTHER SAFETY INFORMATION

  • store at 59°-86° F (15°-30°C)
  • avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, petrolatum

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

zinczinc

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN1
198911zinc oxide 0.2 MG/MG Topical OintmentSCD1
198911zinc oxide 20 % Topical OintmentSY1
198911zinc oxide 200 MG per GM Topical OintmentSY1
198911ZNO 0.2 MG/MG Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-333-452025-01-30C16284748780-12cef2736-75e0-d83d-e063-dadaa90ab31fGenMed ZINC OXIDE Ointment USP with Blue Dye

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-333-45ZINC OXIDE454 g in 1 TUBEOINTMENT4541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-333ZINC OXIDE OINTMENT [​BRANDS INTERNATIONAL]11 package rows20230316_f6f431fa-b2c0-d108-e053-6394a90ae95a.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-33350157-333-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
LIGHT MINERAL OILN6K5787QVPIACT
ZINC OXIDESOI2LOH54ZACTIB

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
f6f431fa-b2c1-d108-e053-6394a90ae95af6f431fa-b2c0-d108-e053-6394a90ae95a2023-03-15WarningsExact identifier
spl id: f6f431fa-b2c1-d108-e053-6394a90ae95a
spl set id: f6f431fa-b2c0-d108-e053-6394a90ae95a

Reported adverse events (FAERS/openFDA)#

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