Classic Care Petroleum

Manufacturer
FDN Enterprises, LLC | ORCHID LIFESCIENCES
Effective date
2021-09-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:42

Label at a glance#

ProductClassic Care Petroleum
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

• temporarily protects minor:  • cuts  • scrapes  • burns  • temporarily protects  and helps relieve chapped or cracked skin and lips  • helps protect from the drying  effects of wind and cold weather.

Dosage and administration

apply as needed 

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP (99.9%)

Purpose

OTC - PURPOSE SECTION

skin protectant

Uses

INDICATIONS & USAGE SECTION

• temporarily protects minor: • cuts  • scrapes  • burns  • temporarily protects  and helps relieve chapped or cracked skin and lips  • helps protect from the drying  effects of wind and cold weather.

Warnings

WARNINGS SECTION

For external use only

When using this product • do not get into eyes.

Do not use on • deep or puncture wounds • laceration or infections • animal bites • serious burns

Stop use and ask doctor if condition lasts more than 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

apply as needed 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water 

SPL UNCLASSIFIED SECTION

PETROLEUM JELLY/ VASELINE

Unscented

Distributed by:

FDN Enterprises, LLC.

Opa Locka, FL 33054.

Made In India

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDN-130FDN-130

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2471403petrolatum 99 % Topical OintmentPSN1
2471403petrolatum 0.99 MG/MG Topical OintmentSCD1
2471403petrolatum 99 % Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60691-130-012023-01-30C16284748780-1f386c649-aa11-0266-e053-dadaa90a7c1aClassic Care ®  Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60691-130-01Classic Care Petroleum1 in 1 BOXJELLY11
60691-130-01Classic Care Petroleum510 g in 1 JARJELLY5101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60691-130CLASSIC CARE PETROLEUM (WHITE PETROLATUM) JELLY [FDN ENTERPRISES, LLC]1Legacy NDC, 2 package rows20211013_81238ed6-4fa9-4de7-a97e-67cfa66c08b6.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60691-13060691-130-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
WATER059QF0KO0RIACT

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
cc251453-84d0-4d71-a5cd-2006e0278df581238ed6-4fa9-4de7-a97e-67cfa66c08b62021-09-15WarningsExact identifier
spl id: cc251453-84d0-4d71-a5cd-2006e0278df5
spl set id: 81238ed6-4fa9-4de7-a97e-67cfa66c08b6

Reported adverse events (FAERS/openFDA)#

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