FDA.reportPublic FDA data

ECZEMA

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

Dosage and administration

dispense a dime-to-quarter sized amount into palm, massage into wet hair starting at the scalp and working to the ends. Rinse. for extra cleansing, allow to sit for 30 seconds and then rinse.

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 and helps relieve minor skin irritation and itching due to:

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

Warnings

WARNINGS SECTION

External use only.

OTC - WHEN USING SECTION

When using this product

  • patch test before use
  • keep out of eyes
  • clean with soap and water to remove
  • to avoid slipping, use mat in tub or shower

OTC - STOP USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • dispense a dime-to-quarter sized amount into palm, massage into wet hair starting at the scalp and working to the ends. Rinse.
  • for extra cleansing, allow to sit for 30 seconds and then rinse.

Other information

ADVERSE REACTIONS 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, decyl glucoside, lauryl glucoside, quillaja saponaria bark extract, glycerine, allantoin, calendula officinalis flower extract, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil, hydrolyzed quinoa, xanthan gum, panthenol, phytic acid, gluconolactone, sodium benzoate.

PRINCIPAL DISPLAY PANEL - 562 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALIF♥RNIA BABY®

TRUSTED
SINCE 1995

eczema therapy

SHAMPOO &
BODYWASH
SKIN PROTECTANT

GLUTEN FREE + STEROID FREE

GENTLE • NON-DRYING • NO ADDED FRAGRANCE

BABIES + KIDS + ADULTS

ALLERGY
TESTED

© 2019

562 mL/19 fl. oz.

Principal Display Panel - 562 mL Bottle Label
Principal Display Panel - 562 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1437616colloidal oatmeal 1 % Medicated ShampooPSN3
1437616colloidal oatmeal 10 MG/ML Medicated ShampooSCD3
1437616colloidal oatmeal 1 % Medicated ShampooSY3

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
52915-010-052020-11-06C16284748780-19855d018-d793-cd31-e053-dbdaa90ab51aECZEMA SHAMPOO & BODYWASH
52915-010-192020-11-06C16284748780-19855d018-d793-cd31-e053-dbdaa90ab51aECZEMA SHAMPOO & BODYWASH
52915-010-052019-11-27C16284748780-19855d018-d793-cd31-e053-dbdaa90ab51aECZEMA SHAMPOO & BODYWASH
52915-010-192019-11-27C16284748780-19855d018-d793-cd31-e053-dbdaa90ab51aECZEMA SHAMPOO & BODYWASH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52915-010-05ECZEMA14 mL in 1 TUBELOTION/SHAMPOO143
52915-010-19ECZEMA562 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO5623
52915-010-85ECZEMA251 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52915-010ECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]3Current NDC, Legacy NDC, 3 package rows20241107_81eb3df4-5beb-45aa-82ca-e8b4b37e45f4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663Y1
OATMEALACTIVE MOIETY8PI54V663Y1
allantoinINACTIVE INGREDIENT344S277G0Z1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
calendula officinalis flowerINACTIVE INGREDIENTP0M7O4Y7YD1
decyl glucosideINACTIVE INGREDIENTZ17H97EA6Y1
fytic acidINACTIVE INGREDIENT7IGF0S7R8I1
gluconolactoneINACTIVE INGREDIENTWQ29KQ9POT1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
jojoba oilINACTIVE INGREDIENT724GKU717M1
lauryl glucosideINACTIVE INGREDIENT76LN7P7UCU1
panthenolINACTIVE INGREDIENTWV9CM0O67Z1
quillaja saponaria barkINACTIVE INGREDIENT8N0K3807ZW1
quinoa oilINACTIVE INGREDIENTM437LS0K521
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1
viola tricolorINACTIVE INGREDIENT9Q24RAI43V1
WaterINACTIVE INGREDIENT059QF0KO0R1
xanthan gumINACTIVE INGREDIENTTTV12P4NEE1
yucca schidigera rootINACTIVE INGREDIENTE2H9ET15AT1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52915-01052915-010-19, 52915-010-05, 52915-010-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
Water059QF0KO0RIACT
decyl glucosideZ17H97EA6YIACT
lauryl glucoside76LN7P7UCUIACT
quillaja saponaria bark8N0K3807ZWIACT
glycerinPDC6A3C0OXIACT
allantoin344S277G0ZIACT
calendula officinalis flowerP0M7O4Y7YDIACT
VIOLA TRICOLOR WHOLE9Q24RAI43VIACT
yucca schidigera rootE2H9ET15ATIACT
aloe vera leafZY81Z83H0XIACT
jojoba oil724GKU717MIACT
quinoa oilM437LS0K52IACT
xanthan gumTTV12P4NEEIACT
panthenolWV9CM0O67ZIACT
fytic acid7IGF0S7R8IIACT
gluconolactoneWQ29KQ9POTIACT
sodium benzoateOJ245FE5EUIACT

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 2 · 116 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
4 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
4 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
4 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
4 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTSPONGE / TOPICALADJ PHExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTCLOTH / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
gluconolactoneGLUCONOLACTONEWQ29KQ9POTSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
12 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii+route
60 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii+route
60 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 BEAUTY81eb3df4-5beb-45aa-82ca-e8b4b37e45f42024-11-05Warnings, Adverse reactionsExact identifier
ndc (package): 52915-010-85
ndc (package): 52915-010-05
ndc (package): 52915-010-19
ndc (product): 52915-010
ndc11 (package): 52915001085
ndc11 (package): 52915001005
ndc11 (package): 52915001019
spl id: 9bcc07a8-7007-4b41-83e2-d147abb7dbb1
spl set id: 81eb3df4-5beb-45aa-82ca-e8b4b37e45f4