ZINC OXIDE OINTMENT USP 20%

Manufacturer
Delsam Pharma Llc
Effective date
2018-10-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:49:33

Label at a glance#

ProductZINC OXIDE
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

• helps treat and prevent diaper rash  • dries the oozing and weeping of:  • poison ivy  • poison oak  • poison sumac

Dosage and administration

For diaper rash • change wet and soiled diapers promptly, allow to dry • apply ointment liberally with each diaper change especially at bedtime or anytime when exposure to wet diapers may be prolonged To dry the oozing and weeping of poison ivy, poison oak, or poison sumac • apply ointment liberally as often as needed.

Storage and handling

• do not use if seal is punctured or is not visible  • use cap to puncture seal  • store at room temperature  • do not exceed 30°C (86°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide USP 20%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

• helps treat and prevent diaper rash  • dries the oozing and weeping of:  • poison ivy  • poison oak  • poison sumac

Warnings

WARNINGS SECTION

For external use only

When using this product  • avoid contact with eyes

Stop use and ask a doctor if  • conditions worsens  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For diaper rash

• change wet and soiled diapers promptly, allow to dry

• apply ointment liberally with each diaper change especially at bedtime or anytime when exposure to wet diapers may be prolonged

To dry the oozing and weeping of poison ivy, poison oak, or poison sumac

• apply ointment liberally as often as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, White Petroleum Jelly

Other information

STORAGE AND HANDLING SECTION

• do not use if seal is punctured or is not visible  • use cap to puncture seal  • store at room temperature  • do not exceed 30°C (86°F)

Questions or comments?

OTC - QUESTIONS SECTION

1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

SPL UNCLASSIFIED SECTION

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zinc109Zinc109

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72570-109-302023-03-16C16284748780-19d75b9d0-8fe3-f424-e053-dadaa90a57ceZINC OXIDE OINTMENT USP 20%
72570-109-302020-01-31C16284748780-19d75b9d0-8fe3-f424-e053-dadaa90a57ceZINC OXIDE OINTMENT USP 20%

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
72570-10972570-109-30

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
ZINC OXIDESOI2LOH54ZACTIM
MINERAL OILT5L8T28FGPIACT
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
4a2c4094-bb64-48f7-b474-78118bfb77d7a66aa9ff-5c1d-4f8d-982e-2d6f6e1301952023-03-15WarningsExact identifier
spl set id: a66aa9ff-5c1d-4f8d-982e-2d6f6e130195

Reported adverse events (FAERS/openFDA)#

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