FDA.reportPublic FDA data

Classic Care

Manufacturer
FDN Enterprises, LLC | Vikshara Trading & Investment Ltd
Effective date
2013-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:44

Label at a glance#

ProductClassic Care Baby
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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP 99.8%

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

OTC - WHEN USING SECTION

  • do not get into eyes.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • laceration or infections
  • animal bites
  • serious burns

OTC - STOP USE SECTION

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

Fragrance

PRINCIPAL DISPLAY PANEL - 368 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Classic Care ®

Soft and gentle as a mother's embrace.

Baby Petroleum Jelly

NET WT 13 OZ (368g)

Principal Display Panel - 368 g Bottle Label
Principal Display Panel - 368 g Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100455petrolatum 99.8 % Topical GelPSN1
1100455petrolatum 0.998 MG/MG Topical GelSCD1
1100455petrolatum 99.8 % Topical GelSY1
1100455petrolatum 99.8 % Topical JellySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60691-123-312019-11-27C16284748780-19855e2a2-3aef-60a7-e053-dbdaa90a05bdClassic Care ® Baby

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60691-123-31Classic Care Baby368 g in 1 CONTAINERJELLY3681

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60691-123CLASSIC CARE BABY (PETROLATUM) JELLY [FDN ENTERPRISES, LLC]1Legacy NDC, 1 package rows20131210_c275462a-0725-4ad8-9b9f-5b9bd9125c25.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PetrolatumACTIVE INGREDIENT4T6H12BN9U1
PetrolatumACTIVE MOIETY4T6H12BN9U1

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
60691-12360691-123-31

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
2fd41533-9341-4f3a-ab97-4326adfb98a8c275462a-0725-4ad8-9b9f-5b9bd9125c252013-12-03WarningsExact identifier
spl id: 2fd41533-9341-4f3a-ab97-4326adfb98a8
spl set id: c275462a-0725-4ad8-9b9f-5b9bd9125c25

Reported adverse events (FAERS/openFDA)#

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