FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Gentell, Inc,. | Gentell,Inc.
Effective date
2017-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:50

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps treat & prevent diaper rash. Protects chafed skin assoicated with diaper rash & helps protect from wetness. Effective for treating poison ivy, poison oak & sumac.

Dosage and administration

Gently cleanse affected area and allow to dry before application. Apply ointment liberally & as often as necessary. For diaper rash, chage wet and soiled diapers promptly. Use with each diaper change, especially when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only.• Avoid contact with eyes.•

Stop use & ask a doctor if condition worsens or does not improve

within 7 days.• Keep out of reach of children.•

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Helps treat & prevent diaper rash.

Protects chafed skin assoicated with diaper rash & helps

protect from wetness. Effective for treating poison ivy,

poison oak & sumac.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Light Mineral Oil & White Petrolatum

Active Ingredients (In each gram)

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20% Skin Protectant

Directions

DOSAGE & ADMINISTRATION SECTION

Gently cleanse affected area and allow to dry before application.

Apply ointment liberally & as often as necessary.

For diaper rash, chage wet and soiled diapers promptly.

Use with each diaper change, especially when exposure to wet

diapers may be prolonged.

Other Information

OTHER SAFETY INFORMATION

Lot Number & Expiration Date; see bottom of container.

Store at controlled room temperature (59ºF - 86ºF).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

For external use only.• Avoid contact with eyes.•

Stop use & ask a doctor if condition worsens or does not improve

within 7 days.• Keep out of reach of children.•

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Helps, treats and prevents diaper rash. Protects chafed skin associaed with diaper rash & helps protect from wetness.

Effective in treating poison ivy, poison oak and sumac.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zinc Oxide OintmentZinc Oxide OintmentGentell Zinc OxideGentell Zinc Oxide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417425zinc oxide 20 % Topical CreamPSN1
417425zinc oxide 200 MG/ML Topical CreamSCD1
417425zinc oxide 20 % Topical CreamSY1
417425ZNO 200 MG/ML Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61554-234-002020-01-31C16284748780-19d75b9d0-8bba-f424-e053-dadaa90a57ce4b58519d-055d-0b28-e054-00144ff8d46c
61554-234-012020-01-31C16284748780-19d75b9d0-8bba-f424-e053-dadaa90a57ce4b58519d-055d-0b28-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61554-234-00Zinc Oxide454 kg in 1 JARCREAM4541
61554-234-01Zinc Oxide28.3 kg in 1 TUBECREAM28.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61554-234ZINC OXIDE (ZINC OXIDE OINTMENT) CREAM [GENTELL, INC,.]1Legacy NDC, 2 package rows20170706_4b58519d-055d-0b28-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-23461554-234-01, 61554-234-00
71395-715

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
LIGHT MINERAL OILN6K5787QVPIACT

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
4b58519d-055e-0b28-e054-00144ff8d46c4b58519d-055d-0b28-e054-00144ff8d46c2017-03-22WarningsExact identifier
spl id: 4b58519d-055e-0b28-e054-00144ff8d46c
spl set id: 4b58519d-055d-0b28-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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