FDA.reportPublic FDA data

Zinc Oxide Ointment USP Drug Facts

Manufacturer
Nivagen Pharmaceuticals, Inc.
Effective date
2025-02-03
Label type
Human OTC Drug Label
Version
6
Source
full-release
Hydrated at
2026-06-01 00:54:49

Label at a glance#

ProductNIVAGEN ZINC OXIDE
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

• Protects skin • Dries the oozing and weeping of poison ivy, oak and sumac • Protects and relieves chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

• Apply ointment liberally as often as necessary • For the treatment of diaper rash, change wet and soiled diapers promptly • Cleanse the diaper area and allow to dry • Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

Storage and handling

• Store at controlled room temperature 15°- 30°C (59°- 86°F). • Avoid excessive heat. Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin.

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

• Protects skin
• Dries the oozing and weeping of poison ivy, oak and sumac
• Protects and relieves chafed skin due to diaper rash and helps seal out wetness

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 condition worsens or does not improve within 7 days.
This may be a sign of a serious condition.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply ointment liberally as often as necessary
• For the treatment of diaper rash, change wet and soiled diapers promptly
• Cleanse the diaper area and allow to dry
• Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

Other Information

STORAGE AND HANDLING SECTION

• Store at controlled room temperature 15°- 30°C (59°- 86°F).
• Avoid excessive heat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 75834-170-01
Zinc Oxide Ointment USP
Zinc Oxide 20%

Skin Protectant
Net Wt. 1 oz. (28.4 g)

Nivagen Pharmaceuticals



carton label 1 oz
carton label 1 oz







NDC 75834-170-02
Zinc Oxide Ointment USP
Zinc Oxide 20%

Skin Protectant
Net Wt. 2 oz. (56.7 g)

Nivagen



carton label 2 oz
carton label 2 oz





NDC 75834-170-15
Zinc Oxide Ointment USP
Zinc Oxide 20%

Skin Protectant
Net Wt. 15 oz. (425 g)

Nivagen



jar label
jar label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN6
198911zinc oxide 0.2 MG/MG Topical OintmentSCD6
198911zinc oxide 20 % Topical OintmentSY6
198911zinc oxide 200 MG per GM Topical OintmentSY6
198911ZNO 0.2 MG/MG Topical OintmentSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-170-012025-02-10C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-022025-02-10C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-152025-02-10C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-012025-01-30C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-022025-01-30C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-152025-01-30C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-012022-02-14C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-022022-02-14C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-152022-02-14C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-012022-01-28C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-022022-01-28C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts
75834-170-152022-01-28C16284748780-1d6a99b39-d304-a426-e053-dadaa90af4c2Zinc Oxide Ointment USP Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-170-01NIVAGEN ZINC OXIDE28.4 g in 1 TUBEOINTMENT28.46
75834-170-02NIVAGEN ZINC OXIDE56.7 g in 1 TUBEOINTMENT56.76
75834-170-15NIVAGEN ZINC OXIDE425 g in 1 JAROINTMENT4256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-170NIVAGEN ZINC OXIDE (ZINC OXIDE) OINTMENT [NIVAGEN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20250212_7b42655b-2163-4637-9f5d-1d2efa1bdf1d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-170-01GM - Gram75834-17023ca029a-7091-40a4-a489-8313dd3bb72412018-09-05
75834-170-02GM - Gram75834-170f8f42b83-1876-4fba-8afb-3e5afc59604112018-09-05
75834-170-15GM - Gram75834-170f19b2880-a7bd-4f80-8848-45964e81175512018-11-06

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
75834-17075834-170-01, 75834-170-02, 75834-170-15

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
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20I835H2IHHXIACT
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
NIVAGEN ZINC OXIDEZINC OXIDENivagen Pharmaceuticals, Inc.7b42655b-2163-4637-9f5d-1d2efa1bdf1d2025-02-03WarningsExact identifier
ndc (package): 75834-170-15
ndc (package): 75834-170-02
ndc (package): 75834-170-01
ndc (product): 75834-170
ndc11 (package): 75834017002
ndc11 (package): 75834017015
ndc11 (package): 75834017001
spl id: 9b087880-cd9b-4a0e-be76-dcb0ad2fd11f
spl set id: 7b42655b-2163-4637-9f5d-1d2efa1bdf1d

Reported adverse events (FAERS/openFDA)#

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