Zinc Oxide Ointment 20%

Manufacturer: Trifecta Pharmaceuticals USA
Effective date: 2018-01-26
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:54:15

Label at a glance#

ProductZinc Oxide 20%

Active ingredientZINC OXIDE

Label structure10 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)

Contacts and useful links#

Websitewww.trifecta-pharma.com

www.trifecta-pharma.com

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 a 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

Mineral Oil, Petrolatum

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Ste. 1500

Ft. Lauderdale, FL. 33301, USA.

Product of PRC

www.trifecta-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zinc PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198911	zinc oxide 20 % Topical Ointment	PSN	2
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	2
198911	zinc oxide 20 % Topical Ointment	SY	2
198911	zinc oxide 200 MG per GM Topical Ointment	SY	2
198911	ZNO 0.2 MG/MG Topical Ointment	SY	2

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0040232454912	GTIN-13: 0040232454912 EAN-13: 0040232454912 GTIN-12: 040232454912 UPC-A: 040232454912 GTIN storage (14 digits): 00040232454912	Zinc PDP.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69396-021-01	2021-01-29	C162847	48780-1	ba0f9c33-4bbf-a910-e053-dadaa90a0b85	Zinc Oxide Ointment 20%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69396-021-01	Zinc Oxide 20%	28 g in 1 TUBE	OINTMENT	28		2
69396-021-01	Zinc Oxide 20%	1 in 1 BOX	OINTMENT	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-021	ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]	2	Current NDC, Legacy NDC, 2 package rows	20180126_61f5aefe-9b43-a616-e053-2a91aa0acdbc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69396-021-02	GM - Gram	69396-021	198fd2a0-5e55-4d19-b613-89aaa71a1421	1	2022-05-04
69396-021-54	GM - Gram	69396-021	17e82a94-c616-4a21-9e5c-b4da32753d8b	1	2023-08-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Zinc Oxide 20%
Zinc Oxide
MINERAL OIL
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69396-021	69396-021-01

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
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB

Source Document#

Source XML · Source PDF

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	8cbe9b1f-fec0-9579-e053-2995a90ac461	2026-06-22	Warnings	Exact identifier ndc (product): 69396-021
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	63b551fc-7d16-c099-e053-2a91aa0a5f2c	2026-05-18	Warnings	Exact identifier ndc (product): 69396-021
63aed61d-57eb-5c6e-e053-2991aa0a282e			61f5aefe-9b43-a616-e053-2a91aa0acdbc	2018-01-26	Warnings	Exact identifier spl id: 63aed61d-57eb-5c6e-e053-2991aa0a282e spl set id: 61f5aefe-9b43-a616-e053-2a91aa0acdbc

Reported adverse events (FAERS/openFDA)#

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