FDA.reportPublic FDA data

Eczema Cream

Manufacturer
Kyte Baby LLC
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:33:35

Label at a glance#

ProductEczema Cream
Active ingredientOATMEAL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug FactsDrug Facts

DOSAGE & ADMINISTRATION SECTION

Directions • Apply liberally to dry or imitated skin as needed. Safe for daily use.Directions • Apply liberally to dry or imitated skin as needed. Safe for daily use.

WARNINGS SECTION

Warnings

For external use only. When using this product, do not get into eyes.

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. Keep out of the reach of children.

If swallowed, get medical advice or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Uses Temporarily protects and helps relieve minor skin irritation and itching due to: • eczema • rashesUses Temporarily protects and helps relieve minor skin irritation and itching due to: • eczema • rashes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

If swallowed, get medical advice or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

ACTIVE INGREDIENT COLLOIDAL OATMEAL 1% PURPOSE SKIN PROTECTANTACTIVE INGREDIENT COLLOIDAL OATMEAL 1% PURPOSE SKIN PROTECTANT

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water (Aqua), Glycerin, Butyrospermum Parkii (Shea Butter, Cetearyl Alcohol, Isostearyl Isostearate, Propanediol, Stearyl Alcohol.

Caprylic/Capric Triglyceride, Arachidyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil, Butylene Glycol, Arachidyl Glucoside, Cynanchum Atratum Extract, Methylheptyglycerin, Sophora Angustifolia Root Extract, Hydroxyacetophenone, Tocopherol, Algin, Caprylhydroxamic Acid, Tetrasodium Glutamate Diacetate, Behenyl Alcohol, Xanthan Gum, Caprylyl Glycol, Nannochloropsis Oculata (Algae) Extract, Citric Acid, Sodium Hydroxide, Hydrogenated Lecithin, 1,2-Hexanediol, Sclerotium

Gum, Arnica Montana Flower Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kyte Skin Eczema CreamKyte Skin Eczema Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN1
240651colloidal oatmeal 10 MG/ML Topical CreamSCD1
240651Avena sativa 1 % Topical CreamSY1
240651colloidal oatmeal 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128197841168294eczema cream label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85303-001-01Eczema Cream100 mL in 1 BOTTLE, PUMPCREAM1001

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85303-00185303-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
TOCOPHEROLR0ZB2556P8IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
BEHENYL ALCOHOL9G1OE216XYIACT
PROPANEDIOL5965N8W85TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOSTEARYL ISOSTEARATEIV0Z586Z4YIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CITRIC ACID2968PHW8QPIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
VINCETOXICUM ATRATUM WHOLEU3176B0S5JIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ALGINC269C4G2ZQIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
SODIUM HYDROXIDE55X04QC32IIACT
OATMEAL8PI54V663YACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
NANNOCHLOROPSIS OCULATAYP8C822TNZIACT
METHYLHEPTYLGLYCERINXX66GGY95EIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT

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
Eczema CreamECZEMA CREAMKyte Baby LLC30c943aa-d9dc-5c16-e063-6294a90a3c582025-03-20WarningsExact identifier
ndc (package): 85303-001-01
ndc (product): 85303-001
ndc11 (package): 85303000101
spl id: 30c943aa-d9dd-5c16-e063-6294a90a3c58
spl set id: 30c943aa-d9dc-5c16-e063-6294a90a3c58

Reported adverse events (FAERS/openFDA)#

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