FDA.reportPublic FDA data

TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM

Manufacturer
Genuine Aloe Virgin Corporation
Effective date
2026-01-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:36:04

Label at a glance#

ProductTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF
Active ingredientOATMEAL
Label structure10 sections

Storage and handling

Other information • store at room temperature • keep carton for important information.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings For external use only

Do not use •on deep puncture wounds •on infections •on lacerations
When using this product •avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop use and ask a doctor if •condition worsens or does not improve within 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.

DOSAGE & ADMINISTRATION SECTION

Directions apply twice a day or as needed.

STORAGE AND HANDLING SECTION

Other information•store at room temperature •keep carton for important information.

INACTIVE INGREDIENT SECTION

Inactive ingredients: water, cetearyl alcohol, urea, isopropyl palmitate, arnica montana flower extract, glycerin, polysorbate 60, cera alba (beeswax), dimethicone, allantoin, zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), butyrospermum parkii (shea) butter, tocopheryl acetate (vitamin E), sodium hyaluronate, cetyl alcohol, sodium phytate, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.
*Certified Organic Ingredient - Mayacert Certifier

OTC - QUESTIONS SECTION

Questions? 1-800-279-7282 M-F 8am-4pm PST

SPL UNCLASSIFIED SECTION

Helps relieve minor skin irritation & itching due to eczema & rashes

Colloidal Oatmeal

Skin Protectant

This concentrated botanical cream helps relieve extra dry, red or irritated skin due to eczema and rashes.



It provides long-lasting moisture and powerful, yet gentle, itch relief.



Enriched with essential botanicals, AP4 ® Organic Aloe* Complex and clinically proven Colloidal Oats, it provides

soothing relief for all ages.

AP4 ® Organic Aloe* Complex - proprietary soothing botanical blend

Colloidal Oats - helps soothe & relieve itching, rashes & eczema

Arnica Montana - known to help soothe irritated skin

Shea Butter - soothes & moisturizes

Vitamins, Beeswax, Allantoin & Zinc PCA


Eczema related symptoms that can appear anywhere on the body.

  • Works quickly
  • Soothes, moisturizes & protects
  • Powerful itch relief


Non-Greasy • No Added Fragrance

Free from Cortisone, Steroids & Parabens

EXPERTS IN SKIN HEALING SINCE 1992

TriDerma MD ® provides healing solutions for irritated skin without harmful side effects.

It all began after one woman struggled to find safe and effective healing for her own skin problem.

This journey led to the creation of our proprietary AP4 ® Organic Aloe* Complex which is key to all our products.

QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE. ®

Each product is made using this powerful complex plus nature’s best botanicals and clinically proven ingredients.

We are passionate in our pursuit to create fast healing products that work.

Learn More at www.triderma.com

Mfd. by: Genuine Virgin Aloe Corp., Anaheim, CA 92807

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

baby eczema 4 carton 1.jpgbaby eczema 4 carton 1.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654721colloidal oatmeal 1.5 % Topical CreamPSN6
1654721colloidal oatmeal 15 MG/ML Topical CreamSCD6
1654721colloidal oatmeal 1.5 % Topical CreamSY6

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
BarcodeEAN-130182228000939GTIN-13: 0182228000939
EAN-13: 0182228000939
GTIN-12: 182228000939
UPC-A: 182228000939
GTIN storage (14 digits): 00182228000939		Stubborn Eczema 4 oz carton.jpg, baby eczema 4 carton 1.jpg, Stubborn Eczema 4 oz label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10738-069-202023-01-31C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-202023-01-31C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-402023-01-31C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-402023-01-31C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-502023-01-31C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-502023-01-31C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-202023-01-30C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-202023-01-30C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-402023-01-30C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-402023-01-30C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-502023-01-30C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM
10738-069-502023-01-30C16284748780-1f386c649-b792-0266-e053-dadaa90a7c1aTRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10738-069-20TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF1 in 1 CARTONCREAM16
10738-069-25TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF62 g in 1 TUBECREAM626
10738-069-40TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF1 in 1 CARTONCREAM16
10738-069-45TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF113 g in 1 TUBECREAM1136

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10738-06910738-069-45, 10738-069-40, 10738-069-25, 10738-069-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PCA469OTG57A2IACT
ZINC PCAC32PQ86DH4IACT
AVENA SATIVA (OAT) KERNEL OIL3UVP41R77RIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
UREA8W8T17847WIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 60CAL22UVI4MIACT
YELLOW WAX2ZA36H0S2VIACT
DIMETHICONE92RU3N3Y1OIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT
SHEA BUTTERK49155WL9YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYALURONATE SODIUMYSE9PPT4THIACT
CETYL ALCOHOL936JST6JCNIACT
PHYTATE SODIUM88496G1ERLIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OATMEAL8PI54V663YACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-01-27monthly-update2026-06-03 17:53:20

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
TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEFCOLLOIDAL OATMEALGenuine Aloe Virgin Corporationf5a83e98-da32-49ae-b81d-4279af4b154c2026-01-29WarningsExact identifier
ndc (package): 10738-069-25
ndc (package): 10738-069-45
ndc (package): 10738-069-40
ndc (package): 10738-069-20
ndc (product): 10738-069
ndc11 (package): 10738006940
ndc11 (package): 10738006925
ndc11 (package): 10738006920
ndc11 (package): 10738006945
spl id: 498d0d4c-7d48-5ff0-e063-6394a90ad849
spl set id: f5a83e98-da32-49ae-b81d-4279af4b154c

Reported adverse events (FAERS/openFDA)#

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