FDA.reportPublic FDA data

Vaseline Clinical Care Eczema Flare-Up Rescue Therapy Cream

Manufacturer
Conopco, Inc. d/b/a/ Unilever
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:36:00

Label at a glance#

ProductVaseline
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: eczema

Dosage and administration

Adults, adolescents, and children over 6 months of age: Apply to affected area as needed

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

VASELINE CLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAM - (colloidal oatmeal) cream

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Colloidal Oatmeal (1.25%)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

temporarily protects and helps relieve minor skin irritation and itching due to:

  • eczema

Warnings

WARNINGS SECTION

For external use only
When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.
Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults, adolescents, and children over 6 months of age:

  • Apply to affected area as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Eau), Glycerin, Stearic Acid, Isopropyl Palmitate, Glycol Stearate, PEG-100 Stearate, Dimethicone, Mineral Oil (Huile Minerale), Glyceryl Stearate, Petrolatum, Cetyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Methylparaben, Triethanolamine, Propylparaben, Stearamide AMP, Disodium EDTA, Disodium EDTA, Hydroxystearic Acid.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-457-7084

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vaseline Eczema Therapy CreamVaseline Eczema Therapy Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2530893colloidal oatmeal 1.25 % Topical CreamPSN4
2530893colloidal oatmeal 12.5 MG/ML Topical CreamSCD4
2530893colloidal oatmeal 1.25 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64942-1872-1Vaseline89 mL in 1 BOTTLE, PUMPCREAM894
64942-1872-2Vaseline1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64942-1872VASELINE (CLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAM) CREAM [CONOPCO, INC. D/B/A/ UNILEVER]4Current NDC, Legacy NDC, 2 package rows20241109_bd206830-e334-3764-e053-2995a90a74ca.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64942-187264942-1872-1, 64942-1872-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
GLYCOL STEARATE0324G66D0EIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PETROLATUM4T6H12BN9UIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
STEARAMIDE AMPU3K8640346IACT
EDETATE DISODIUM7FLD91C86KIACT
PEG-100 STEARATEYD01N1999RIACT
MINERAL OILT5L8T28FGPIACT
OATMEAL8PI54V663YACTIB
12-HYDROXYSTEARIC ACID933ANU3H2SIACT

Source Document#

Source XML

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VaselineCLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAMConopco, Inc. d/b/a/ Unileverbd206830-e334-3764-e053-2995a90a74ca2024-11-07WarningsExact identifier
ndc (package): 64942-1872-2
ndc (package): 64942-1872-1
ndc (product): 64942-1872
ndc11 (package): 64942187201
ndc11 (package): 64942187202
spl id: 2652aa5b-05d3-8c34-e063-6394a90a048d
spl set id: bd206830-e334-3764-e053-2995a90a74ca