FDA.reportPublic FDA data

ECZEMA CREAM

Manufacturer
ORGANIC & SUSTAINABLE BEAUTY
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:34:30

Label at a glance#

ProductECZEMA
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

Temporarily protects & helps relieve minor skin irritation and itching due to: Rashes Eczema Poison ivy, oak, or sumac Insect bites

Dosage and administration

Apply liberally onto desired area Reapply as needed. Children under 6 months: ask a doctor. Use in combination with our Eczema Shampoo & Bodywash.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects & helps relieve minor skin irritation and itching due to:

  • Rashes
  • Eczema
  • Poison ivy, oak, or sumac
  • Insect bites

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 swallowed, get medical help or contact Poison Control within the U.S. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally onto desired area

  • Reapply as needed. Children under 6 months: ask a doctor. Use in combination with our Eczema Shampoo & Bodywash.

Other information

SPL UNCLASSIFIED SECTION

You may report a serious adverse reaction event from using this product to: 5933 Bowcroft St. Los Angeles, CA 90016.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, calendula officinalis flower extract, caprylic/capric triglyceride, cetyl alcohol, stearic acid, cetearyl olivate, sorbitan olivate, canola oil, allantoin, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, rosmarinus officinalis leaf extract, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, phytic acid, caprylhydroxamic acid, glyceryl caprylate.

PRINCIPAL DISPLAY PANEL - 133 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALIF♥RNIA BABY®
TRUSTED SINCE 1995

therapeutic relief™

GLUTEN-FREE!
ECZEMA
CREAM
SKIN PROTECTANT

OATMEAL & CALENDULA
HELPS HEAL & PROTECT DELICATE SKIN
FOR BABIES, KIDS & SENSITIVE ADULTS

ALLERGY
TESTED

133 mL/4.5 fl. oz.

PRINCIPAL DISPLAY PANEL - 133 mL Container Label
PRINCIPAL DISPLAY PANEL - 133 mL Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN3
240651colloidal oatmeal 10 MG/ML Topical CreamSCD3
240651Avena sativa 1 % Topical CreamSY3
240651colloidal oatmeal 1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52915-120-052020-11-09C16284748780-19855d018-ea47-cd31-e053-dbdaa90ab51aECZEMA CREAM
52915-120-192020-11-09C16284748780-19855d018-ea47-cd31-e053-dbdaa90ab51aECZEMA CREAM
52915-120-452020-11-09C16284748780-19855d018-ea47-cd31-e053-dbdaa90ab51aECZEMA CREAM
52915-120-052019-11-27C16284748780-19855d018-ea47-cd31-e053-dbdaa90ab51aECZEMA CREAM
52915-120-192019-11-27C16284748780-19855d018-ea47-cd31-e053-dbdaa90ab51aECZEMA CREAM
52915-120-452019-11-27C16284748780-19855d018-ea47-cd31-e053-dbdaa90ab51aECZEMA CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52915-120-02ECZEMA57 mL in 1 JARCREAM573
52915-120-05ECZEMA14 mL in 1 TUBECREAM143
52915-120-19ECZEMA562 mL in 1 BOTTLE, PUMPCREAM5623
52915-120-45ECZEMA133 mL in 1 CONTAINERCREAM1333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52915-120ECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]3Current NDC, Legacy NDC, 4 package rows20241107_926706b5-0a08-4604-b5ad-3b3ddfd7f02d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663Y1
OATMEALACTIVE MOIETY8PI54V663Y1
allantoinINACTIVE INGREDIENT344S277G0Z1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
calendula officinalis flowerINACTIVE INGREDIENTP0M7O4Y7YD1
canola oilINACTIVE INGREDIENT331KBJ17RK1
caprylhydroxamic acidINACTIVE INGREDIENTUPY805K99W1
cetearyl olivateINACTIVE INGREDIENT58B69Q84JO1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
clary sage oilINACTIVE INGREDIENT87L0D4U3M01
fytic acidINACTIVE INGREDIENT7IGF0S7R8I1
glyceryl caprylateINACTIVE INGREDIENTTM2TZD4G4A1
lavender oilINACTIVE INGREDIENTZBP1YXW0H81
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7U1
rosemaryINACTIVE INGREDIENTIJ67X351P91
sorbitan olivateINACTIVE INGREDIENTMDL271E3GR1
stearic acidINACTIVE INGREDIENT4ELV7Z65AP1
viola tricolorINACTIVE INGREDIENT9Q24RAI43V1
WaterINACTIVE INGREDIENT059QF0KO0R1
yucca schidigera rootINACTIVE INGREDIENTE2H9ET15AT1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52915-12052915-120-45, 52915-120-05, 52915-120-02, 52915-120-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
Water059QF0KO0RIACT
medium-chain triglyceridesC9H2L21V7UIACT
cetyl alcohol936JST6JCNIACT
stearic acid4ELV7Z65APIACT
cetearyl olivate58B69Q84JOIACT
sorbitan olivateMDL271E3GRIACT
canola oil331KBJ17RKIACT
allantoin344S277G0ZIACT
calendula officinalis flowerP0M7O4Y7YDIACT
VIOLA TRICOLOR WHOLE9Q24RAI43VIACT
yucca schidigera rootE2H9ET15ATIACT
aloe vera leafZY81Z83H0XIACT
rosemaryIJ67X351P9IACT
lavender oilZBP1YXW0H8IACT
clary sage oil87L0D4U3M0IACT
fytic acid7IGF0S7R8IIACT
caprylhydroxamic acidUPY805K99WIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 35 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ATABLET / ORAL1 mgExact identifier — unii candidate
10 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ACAPSULE / ORAL400 mgExact identifier — unii candidate
10 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
5 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ACAPSULE / ORAL400 mgExact identifier — unii candidate
10 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ATABLET / ORAL1 mgExact identifier — unii candidate
10 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ATABLET / ORAL1 mgExact identifier — unii candidate
10 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ATABLET / ORAL1 mgExact identifier — unii candidate
10 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ACAPSULE / ORAL400 mgExact identifier — unii candidate
10 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ACAPSULE / ORAL400 mgExact identifier — unii candidate
10 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ATABLET / ORAL1 mgExact identifier — unii candidate
10 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
5 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
lavender oilLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
5 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
lavender oilLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
5 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
lavender oilLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
5 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
5 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
5 equally ranked IID candidates
lavender oilLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
5 equally ranked IID candidates
glyceryl caprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ACAPSULE / ORAL400 mgExact identifier — unii candidate
10 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
5 equally ranked IID candidates
lavender oilLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
5 equally ranked IID candidates

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
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY926706b5-0a08-4604-b5ad-3b3ddfd7f02d2024-11-05WarningsExact identifier
ndc (package): 52915-120-19
ndc (package): 52915-120-45
ndc (package): 52915-120-05
ndc (package): 52915-120-02
ndc (product): 52915-120
ndc11 (package): 52915012005
ndc11 (package): 52915012002
ndc11 (package): 52915012019
ndc11 (package): 52915012045
spl id: 5fe6372b-07b4-40f8-9efe-2892256f2454
spl set id: 926706b5-0a08-4604-b5ad-3b3ddfd7f02d

Reported adverse events (FAERS/openFDA)#

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