FDA.reportPublic FDA data

Vitamin A and D Ointment

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:47:26

Label at a glance#

ProductVitamin A and D
Active ingredientPETROLATUM, LANOLIN
Label structure11 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

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

Storage and handling

Store at controlled room temperature 20º 25ºC (68º-77ºF) Questions 1-888-296-9067

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lanolin 15.5%

Petrolatum 53.4%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash and helps seal out wetness

Stop use and ask a doctor

OTC - STOP USE SECTION

Condition worsens

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

Keep our 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

Change wet and soiled diapers promptly

Cleanse the diaper area and allow to dry

Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cod liver oil (contains Vitamin A and Vitamin D), Fragrance, Mineral Oil, Microcrystalline Wax, Paraffin

SPL UNCLASSIFIED SECTION

Distributed by

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

Product of PRC

www.trifecta-pharma.com

Warnings

WARNINGS SECTION

For external use only

When using this product avoid contact with eyes

STORAGE AND HANDLING SECTION

Store at controlled room temperature 20º 25ºC (68º-77ºF)

Questions 1-888-296-9067

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

globe_vitamin_ADglobe_vitamin_AD

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN4
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD4
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY4
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-009-20Vitamin A and D15 g in 1 TUBEOINTMENT154
69396-009-20Vitamin A and D1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-009VITAMIN A AND D (LANOLIN, PETROLATUM) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]4Current NDC, Legacy NDC, 2 package rows20241222_453dffec-de9d-0eac-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-00969396-009-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UACTIB
COD LIVER OILBBL281NWFGIACT
MINERAL OILT5L8T28FGPIACT
LANOLIN7EV65EAW6HACTIB

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
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC453dffec-de9d-0eac-e054-00144ff8d46c2024-12-20WarningsExact identifier
ndc (package): 69396-009-20
ndc (product): 69396-009
ndc11 (package): 69396000920
spl id: 29b3cf7a-794a-6a29-e063-6294a90ac3d7
spl set id: 453dffec-de9d-0eac-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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