FDA.reportPublic FDA data

Zinc Oxide Ointment 20%

Manufacturer
PHARMAMED USA INC
Effective date
2026-05-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
weekly-update
Hydrated at
2026-06-03 18:02:31

Label at a glance#

ProductPROSKI ZINCO SKIN PROTECTANT
Active ingredientZINC OXIDE
Label structure10 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.

Storage and handling

Store at room temperature between 15º - 30ºC (59º - 86ºF) Avoid excessive heat Tamper evident. Do not use if seal is damaged.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USE

INDICATIONS & USAGE SECTION

  • Helps treat chafed skin associated with diaper rash. Protects chafed skin due to diaper rash and helps protect from wetness.
  • Dries the oozing and weeping of poison: • ivy • oak •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

STORAGE AND HANDLING SECTION

  • 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

CETETH-20, CETOSTEARYL ALCOHOL, LIGHT MINERAL OIL, WHITE PETROLATUM

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)

Recent Major Changes (§ 201.57(a)(5)) Rev 05-05-2026

RECENT MAJOR CHANGES SECTION

• Boxed Warning
• Indications and Usage
• Dosage and Administration
• Contraindications
• Warnings and Precautions

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 84289-119-20

ZINC OXIDE OINTMENT

Skin Protectant

Net Wt 1 oz. (28.4 g)

GOA/DRUGS/571

Inner Label ImageInner Label Image

Outer Label ImageOuter Label Image

Pinted InsertPinted Insert

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
84289-11984289-119-20

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
CETETH-20I835H2IHHXIACT
ZINC OXIDESOI2LOH54ZACTIB
LIGHT MINERAL OILN6K5787QVPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WHITE PETROLATUMB6E5W8RQJ4IACT

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
5259ea38-cc92-13aa-e063-6294a90a1efc2cb7f314-beb4-e57f-e063-6394a90ad3ef2026-05-21WarningsExact identifier
spl set id: 2cb7f314-beb4-e57f-e063-6394a90ad3ef

Reported adverse events (FAERS/openFDA)#

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