Globe White Petrolatum Ointment

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:04

Label at a glance#

ProductWhite Petrolatum
Active ingredientPETROLATUM
Label structure14 sections

Indications and uses

Temporarily protects and relieves minor cuts scrapes burns chapped or cracked skin and lips

Dosage and administration

Apply as needed

Storage and handling

Store at room temperature 20º-25ºC (68º-77ºF) Tamper evident, do not use if packet is torn, cut or opened Avoid excessive heat and humidity

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 100%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and relieves

  • minor cuts
  • scrapes
  • burns
  • chapped or cracked skin and lips

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 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

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes

Do Not Use

OTC - DO NOT USE SECTION

  • On deep or puncture wounds
  • Animal Bites
  • Serious Burns

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, vitamin A Palmitate, vitamin D3, Microcrystalline Wax, Paraffin

SPL UNCLASSIFIED SECTION

Distributed By

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

www.trifecta-pharma.com

1-888-296-9067

Warnings

WARNINGS SECTION

For external use only

Questions

OTC - QUESTIONS SECTION

Call: 1-888-296-9067

STORAGE AND HANDLING SECTION

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

Tamper evident, do not use if packet is torn, cut or opened

Avoid excessive heat and humidity

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Globe White Petrolatum 5g CDERGlobe White Petrolatum 5g CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN2
204754petrolatum 1 MG/MG Topical OintmentSCD2
204754petrolatum 100 % Topical JellySY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-114-05White Petrolatum144 in 1 CARTONOINTMENT1442
69396-114-05White Petrolatum5 g in 1 PACKETOINTMENT52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-114WHITE PETROLATUM (PETROLATUM) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, Legacy NDC, 2 package rows20241222_f1eb0ec2-98e7-13a2-e053-2a95a90a2938.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-11469396-114-05

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB

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
White PetrolatumPETROLATUMTrifecta Pharmaceuticals USA LLCf1eb0ec2-98e7-13a2-e053-2a95a90a29382024-12-20WarningsExact identifier
ndc (package): 69396-114-05
ndc (product): 69396-114
ndc11 (package): 69396011405
spl id: 29b3e33a-5451-40b4-e063-6394a90a1107
spl set id: f1eb0ec2-98e7-13a2-e053-2a95a90a2938

Reported adverse events (FAERS/openFDA)#

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