FDA.reportPublic FDA data

1190, 1191, 1192 Zinc Oxide Ointment 20%

Manufacturer
Dynarex Corporation
Effective date
2026-04-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:53:30

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure11 sections

Dosage and administration

• For diaper rash: 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 bedtime or anytime when exposure to wet diapers may be prolonged. • For poison ivy, oak, and sumac: Apply as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use(s)

INDICATIONS & USAGE SECTION

• Helps treat chafed skin associated with diaper rash

• Dries the oozing and weeping of poison ivy, oak, and sumac

Warnings

WARNINGS SECTION

For External Use Only

When using this product

OTC - WHEN USING SECTION

• Avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days

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 (1-800-222-1222) 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 as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

• For poison ivy, oak, and sumac: Apply as needed.

Other Information

OTHER SAFETY INFORMATION

• Store at room temperature between 15º-30ºC (59º-86ºF)

• Avoid excessive heat

• Tamper evident. Do not use if seal is damaged.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetomacrogol 1000. Cetostearyl Alcohol Light Liquid Paraffin, White Soft Paraffin

Questions?

OTC - QUESTIONS SECTION

1-888-Dynarex Monday - Friday, 9AM - 5PM EST.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1192_IN_MASTER1192_IN_MASTERLabel 1192

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1190_BX_MASTER1190_BX_MASTERLabel 1190

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1191_BX_MASTER1191_BX_MASTERLabel 1191

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN2
198911zinc oxide 0.2 MG/MG Topical OintmentSCD2
198911zinc oxide 20 % Topical OintmentSY2
198911zinc oxide 200 MG per GM Topical OintmentSY2
198911ZNO 0.2 MG/MG Topical OintmentSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130616784119014GTIN-13: 0616784119014
EAN-13: 0616784119014
GTIN-12: 616784119014
UPC-A: 616784119014
GTIN storage (14 digits): 00616784119014		1190_BX_MASTER_R240131-3.jpg
BarcodeEAN-130616784119113GTIN-13: 0616784119113
EAN-13: 0616784119113
GTIN-12: 616784119113
UPC-A: 616784119113
GTIN storage (14 digits): 00616784119113		1191_BX_MASTER_R240131-3.jpg
BarcodeEAN-130616784119212GTIN-13: 0616784119212
EAN-13: 0616784119212
GTIN-12: 616784119212
UPC-A: 616784119212
GTIN storage (14 digits): 00616784119212		1192_IN_MASTER_R240131-4.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-223-01Zinc Oxide28.4 g in 1 TUBEOINTMENT28.42
67777-223-02Zinc Oxide72 in 1 CASEOINTMENT722
67777-223-03Zinc Oxide56.7 g in 1 TUBEOINTMENT56.72
67777-223-04Zinc Oxide72 in 1 CASEOINTMENT722
67777-223-05Zinc Oxide425 g in 1 JAROINTMENT4252
67777-223-06Zinc Oxide12 in 1 CASEOINTMENT122
67777-223-11Zinc Oxide1 in 1 BOXOINTMENT12
67777-223-13Zinc Oxide1 in 1 BOXOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-223-02GM - Gram67777-223a1aba020-1f07-40bb-8d4d-dacb4126d9c912025-02-10
67777-223-04GM - Gram67777-2239b55a253-7da3-4029-ab9a-2dfba1170e1512025-02-10
67777-223-11GM - Gram67777-2235155c86f-1630-4ac9-b36b-9c3b9aaf67f712025-02-10
67777-223-13GM - Gram67777-2238f27eee2-84fa-4b25-8b80-9b847af3237c12025-02-10

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
67777-22367777-223-01, 67777-223-11, 67777-223-02, 67777-223-03, 67777-223-13, 67777-223-04, 67777-223-05, 67777-223-06

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
ZINC OXIDESOI2LOH54ZACTIB
WHITE PETROLATUMB6E5W8RQJ4IACT
LIGHT MINERAL OILN6K5787QVPIACT
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
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
ndc (package): 67777-223-01
ndc (package): 67777-223-03
ndc (package): 67777-223-02
ndc (package): 67777-223-05
ndc (package): 67777-223-06
ndc (package): 67777-223-11
ndc (package): 67777-223-13
ndc (package): 67777-223-04
ndc (product): 67777-223
ndc11 (package): 67777022313
ndc11 (package): 67777022304
ndc11 (package): 67777022305
ndc11 (package): 67777022302
ndc11 (package): 67777022303
ndc11 (package): 67777022301
ndc11 (package): 67777022306
ndc11 (package): 67777022311
spl id: 4f5b6507-0292-edc3-e063-6294a90a3c79
spl set id: 11d79dd6-35f7-4399-e063-6294a90ac7dd

Reported adverse events (FAERS/openFDA)#

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