FDA.reportPublic FDA data

Zinc Oxide Ointment 20%

Manufacturer
Pharmacy Value Alliance, LLC | Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:23

Label at a glance#

ProductZinc Oxide 20%
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin due to diaper rash - helps protect skin from wetness Protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips

Dosage and administration

Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply ointment liberally as often as necessary. With each diaper change, especially at betime or anytime when exposure to wet diapers may be prolonged

Storage and handling

Store at controlled room temperature 20° - 25°C (68° - 77°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

  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash - helps protect skin from wetness
  • Protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac
  • Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips

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

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply ointment liberally as often as necessary. With each diaper change, especially at betime or anytime when exposure to wet diapers may be prolonged

Other Information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 20° - 25°C (68° - 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Petrolatum

Distributed By:

SPL UNCLASSIFIED SECTION

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Emerson Zinc OxideEmerson Zinc Oxide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN5
198911zinc oxide 0.2 MG/MG Topical OintmentSCD5
198911zinc oxide 20 % Topical OintmentSY5
198911zinc oxide 200 MG per GM Topical OintmentSY5
198911ZNO 0.2 MG/MG Topical OintmentSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-159-022023-05-09C16284748780-1ba0f9c33-3750-a910-e053-dadaa90a0b85Zinc Oxide Ointment 20%
68016-159-022023-01-30C16284748780-1ba0f9c33-3750-a910-e053-dadaa90a0b85Zinc Oxide Ointment 20%
68016-159-022021-08-10C16284748780-1ba0f9c33-3750-a910-e053-dadaa90a0b85Zinc Oxide Ointment 20%
68016-159-022021-01-29C16284748780-1ba0f9c33-3750-a910-e053-dadaa90a0b85Zinc Oxide Ointment 20%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-159-02Zinc Oxide 20%1 in 1 BOXOINTMENT15
68016-159-02Zinc Oxide 20%57 g in 1 TUBEOINTMENT575

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-159ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [PHARMACY VALUE ALLIANCE, LLC]5Current NDC, Legacy NDC, 2 package rows20241222_38018e3f-3778-01d1-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
68016-15968016-159-02

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
ZINC OXIDESOI2LOH54ZACTIB
PETROLATUM4T6H12BN9UIACT

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
Zinc Oxide 20%ZINC OXIDEPharmacy Value Alliance, LLC38018e3f-3778-01d1-e054-00144ff8d46c2024-12-20WarningsExact identifier
ndc (package): 68016-159-02
ndc (product): 68016-159
ndc11 (package): 68016015902
spl id: 29b7387b-ad70-3a11-e063-6394a90a6a15
spl set id: 38018e3f-3778-01d1-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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