FDA.reportPublic FDA data

Zinc Oxide Ointment 20%

Manufacturer
BluePoint Laboratories | Gopaldas Visram & Co., Ltd
Effective date
2023-11-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:26

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

• Dries the oozing and weeping of poison: • Ivy • Oak • Sumac

Dosage and administration

For poison ivy, oak, and sumac: apply as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

• 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

• Do not get into eyes

• Do not use over large areas of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

• The condition worsens

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

• You are allergic to any of these ingredients

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For poison ivy, oak, and sumac: apply as needed.

Other Information

OTHER SAFETY INFORMATION

  • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
  • Store at room temperature.
    • Preserve in well-closed container.
    • See crimp of tube or carton for Lot number and Expiry Date.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 20, White Petrolatum.

Questions?

OTC - QUESTIONS SECTION

Contact 1-800-707-4621

Gopaldas Visram & Company Limited.

Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

Mahape, Navi Mumbai- 400710.

For BluePoint Laboratories

Tube and carton 30 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton label 30 gCarton label 30 gTube label 30 gTube label 30 g

Tube and carton 60 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton label 60 gCarton label 60 gTube label 60 gTube label 60 g

Jar Label 454 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jar Label 454 gJar Label 454 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN3
198911zinc oxide 0.2 MG/MG Topical OintmentSCD3
198911zinc oxide 20 % Topical OintmentSY3
198911zinc oxide 200 MG per GM Topical OintmentSY3
198911ZNO 0.2 MG/MG Topical OintmentSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-532-45Zinc Oxide1 in 1 CARTONOINTMENT13
68001-532-45Zinc Oxide30 g in 1 TUBEOINTMENT303
68001-532-46Zinc Oxide1 in 1 CARTONOINTMENT13
68001-532-46Zinc Oxide60 g in 1 TUBEOINTMENT603
68001-533-50Zinc Oxide454 g in 1 JAROINTMENT4543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-532ZINC OXIDE (SKIN PROTECTANT) OINTMENT [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 4 package rows20231118_d9b752e6-655a-19a6-e053-2995a90a9a37.zip
68001-533ZINC OXIDE (SKIN PROTECTANT) OINTMENT [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 1 package rows20231118_d9b752e6-655a-19a6-e053-2995a90a9a37.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-532-45GM - Gram68001-532669ed332-a5a8-4bca-9d28-81f40c7bbd6312022-08-04
68001-532-46GM - Gram68001-532217d5eb8-6481-46d3-9782-36cbb0063f5412022-08-04
68001-533-50GM - Gram68001-53351c50c84-2bd8-4871-864a-4320b3988e3f12022-08-04

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
68001-53268001-532-45, 68001-532-46
68001-53368001-533-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIGHT MINERAL OILN6K5787QVPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
ZINC OXIDESOI2LOH54ZACTIB
LIGHT MINERAL OILN6K5787QVPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
ZINC OXIDESOI2LOH54ZACTIB

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 OxideSKIN PROTECTANTBluePoint Laboratoriesd9b752e6-655a-19a6-e053-2995a90a9a372023-11-17WarningsExact identifier
ndc (package): 68001-532-45
ndc (package): 68001-533-50
ndc (package): 68001-532-46
ndc (product): 68001-533
ndc (product): 68001-532
ndc11 (package): 68001053246
ndc11 (package): 68001053245
ndc11 (package): 68001053350
spl id: 097e3a92-864a-aef4-e063-6294a90abcf3
spl set id: d9b752e6-655a-19a6-e053-2995a90a9a37

Reported adverse events (FAERS/openFDA)#

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