FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Derma Sciences Canada Inc. | Derma Sciences Canada, Inc
Effective date
2025-06-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:30

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure14 sections

Storage and handling

Other Information store between 15ºC to 30ºC (59ºF to 86ºF) avoid excessive heat

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes

INACTIVE INGREDIENT SECTION

light mineral oil, petrolatum

OTC - DO NOT USE SECTION

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

OTC - PURPOSE SECTION

Skin Protectant

WARNINGS SECTION

Warnings

For external use only

When using this product

■ do not get into eyes

Stop use and ask a doctor if

■ condition worsens

■ symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

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

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.

OTC - QUESTIONS SECTION

Questions?

Call 800-840-9041 Monday through Friday 9:00 AM to 5:00 PM EST

STORAGE AND HANDLING SECTION

Other Information

store between 15ºC to 30ºC (59ºF to 86ºF)

avoid excessive heat

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply as needed

INDICATIONS & USAGE SECTION

Uses

dries the oozing and weeping of:

■ poison ivy ■ poison oak ■ poison sumac

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zinc Oxide Ointment 16ozZinc Oxide Ointment 16oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN1
198911zinc oxide 0.2 MG/MG Topical OintmentSCD1
198911zinc oxide 20 % Topical OintmentSY1
198911zinc oxide 200 MG per GM Topical OintmentSY1
198911ZNO 0.2 MG/MG Topical OintmentSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64772-201-01Zinc Oxide453.6 g in 1 JAROINTMENT453.61

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
64772-20164772-201-01

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 OXIDESOI2LOH54ZACTIB
PETROLATUM4T6H12BN9UIACT
LIGHT MINERAL OILN6K5787QVPIACT

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 OINTMENTDerma Sciences Canada Inc.37eff762-1ea9-ec66-e063-6394a90a3d102025-06-19WarningsExact identifier
ndc (package): 64772-201-01
ndc (product): 64772-201
ndc11 (package): 64772020101
spl id: 37eff762-1eaa-ec66-e063-6394a90a3d10
spl set id: 37eff762-1ea9-ec66-e063-6394a90a3d10

Reported adverse events (FAERS/openFDA)#

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