FDA.reportPublic FDA data

Zinc Oxide Ointment 20%

Manufacturer
Trifecta Pharmaceuticals USA
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:39

Label at a glance#

ProductZinc Oxide 20%
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

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

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)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

WARNINGS SECTION

For External Use Only

  • When using this product avoid contact with eyes

Stop Use and ask Doctor if

OTC - STOP USE SECTION

Stop use and ask doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

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)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetomacrogol 1000, Cetostearyl alcohol, Light Mineral Oil, White Petrolatum

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.®

101 NE Third Avenue, Ste. 1500

Ft. Lauderdale, FL. 33301, USA.

www.trifecta-pharma.com

Questions

OTC - QUESTIONS SECTION

Call 1-888-296-9067

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Globe Zinc Oxide Ointment 2oz India Rev09 042323 CDERGlobe Zinc Oxide Ointment 2oz India Rev09 042323 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN2
198911zinc oxide 0.2 MG/MG Topical OintmentSCD2
198911zinc oxide 20 % Topical OintmentSY2
198911zinc oxide 200 MG per GM Topical OintmentSY2
198911ZNO 0.2 MG/MG Topical OintmentSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-086-02Zinc Oxide 20%60 g in 1 TUBEOINTMENT602
69396-086-02Zinc Oxide 20%1 in 1 BOXOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-086ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]2Current NDC, 2 package rows20240120_fcef17f1-84e7-a288-e053-6294a90a064b.zip

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
69396-08669396-086-02

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
WHITE PETROLATUMB6E5W8RQJ4IACT
CETETH-20I835H2IHHXIACT
LIGHT MINERAL OILN6K5787QVPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
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 Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USAfcef17f1-84e7-a288-e053-6294a90a064b2024-01-19WarningsExact identifier
ndc (package): 69396-086-02
ndc (product): 69396-086
ndc11 (package): 69396008602
spl id: 0f4e022b-3f1e-96dc-e063-6294a90ad3b7
spl set id: fcef17f1-84e7-a288-e053-6294a90a064b

Reported adverse events (FAERS/openFDA)#

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