FDA.reportPublic FDA data

Zinc Oxide Ointment 20%

Manufacturer
Trifecta Pharmaceuticals USA
Effective date
2026-06-22
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
monthly-update
Hydrated at
2026-07-17 21:35:06

Label at a glance#

ProductZinc Oxide 20%
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Protects skin Protects and releives chafed skin due to diaper rash - helps seal out wetness Dries the oozing and weeping of poison ivy, oak and sumac

Dosage and administration

Apply ointment liberally as often as necessary For the treatment of diaper rash, change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

Storage and handling

Store at controlled room temperature 15° - 30°C (59° - 86°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Protects skin
  • Protects and releives chafed skin due to diaper rash - helps seal out wetness
  • Dries the oozing and weeping of poison ivy, oak and sumac

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings

WARNINGS SECTION

For External Use Only

  • When using this product avoid contact with eyes
  • Stop use and ask a doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply ointment liberally as often as necessary
  • For the treatment of diaper rash, change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

Other Information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Petrolatum

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Ste. 1500

Ft. Lauderdale, FL. 33301, USA.

www.trifecta-pharma.com

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4559 GLOBE ZINC OXIDE OINTMENT 16OZ UPC REV10 122022 CDER4559 GLOBE ZINC OXIDE OINTMENT 16OZ UPC REV10 122022 CDER

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860001004922GTIN-13: 0860001004922
EAN-13: 0860001004922
GTIN-12: 860001004922
UPC-A: 860001004922
GTIN storage (14 digits): 00860001004922		4559 GLOBE ZINC OXIDE OINTMENT 16OZ UPC REV10 122022 CDER.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69396-021-542023-04-24C16284748780-1f386c649-de87-0266-e053-dadaa90a7c1aZinc Oxide Ointment 20%
69396-021-542023-04-24C16284748780-1f386c649-de87-0266-e053-dadaa90a7c1aZinc Oxide Ointment 20%
69396-021-542023-01-30C16284748780-1f386c649-de87-0266-e053-dadaa90a7c1aZinc Oxide Ointment 20%
69396-021-542023-01-30C16284748780-1f386c649-de87-0266-e053-dadaa90a7c1aZinc Oxide Ointment 20%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-021-02GM - Gram69396-021198fd2a0-5e55-4d19-b613-89aaa71a142112022-05-04
69396-021-54GM - Gram69396-02117e82a94-c616-4a21-9e5c-b4da32753d8b12023-08-08

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
69396-02169396-021-54

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
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92026-05-18full-release2026-06-01 01:57:57

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA8cbe9b1f-fec0-9579-e053-2995a90ac4612026-06-22WarningsExact identifier
ndc (package): 69396-021-54
ndc (product): 69396-021
ndc11 (package): 69396002154
spl id: 54d824fe-18b9-42a4-e063-6294a90af322
spl set id: 8cbe9b1f-fec0-9579-e053-2995a90ac461
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA63b551fc-7d16-c099-e053-2a91aa0a5f2c2026-05-18WarningsExact identifier
ndc (product): 69396-021

Reported adverse events (FAERS/openFDA)#

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