FDA.reportPublic FDA data

Zinc Oxide Ointment (1 oz and 2 oz)

Manufacturer
Sabel Med LLC
Effective date
2016-04-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:50

Label at a glance#

ProductAftate Zinc Oxide
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredientInactive ingredient

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reachKeep out of reach

OTC - PURPOSE SECTION

purposepurpose

DOSAGE & ADMINISTRATION SECTION

DosageDosage

INDICATIONS & USAGE SECTION

usageusage

WARNINGS SECTION

warningswarnings

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principle displayprinciple display

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
70356-326-012020-01-31C16284748780-19d75b9d1-26c4-f424-e053-dadaa90a57ceZinc Oxide Ointment (1 oz and 2 oz)
70356-326-022020-01-31C16284748780-19d75b9d1-26c4-f424-e053-dadaa90a57ceZinc Oxide Ointment (1 oz and 2 oz)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70356-326-01Aftate Zinc Oxide28 g in 1 TUBEOINTMENT281
70356-326-02Aftate Zinc Oxide56 g in 1 TUBEOINTMENT561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70356-326AFTATE ZINC OXIDE (ZINC OXIDE) OINTMENT [SABEL MED LLC]1Legacy NDC, 2 package rows20160501_2fd39d46-98e4-42a7-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70356-32670356-326-02, 70356-326-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
MINERAL OILT5L8T28FGPIACT
ZINC OXIDESOI2LOH54ZACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20I835H2IHHXIACT

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
2fd39d46-98e5-42a7-e054-00144ff88e882fd39d46-98e4-42a7-e054-00144ff88e882016-04-06WarningsExact identifier
spl id: 2fd39d46-98e5-42a7-e054-00144ff88e88
spl set id: 2fd39d46-98e4-42a7-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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