FDA.reportPublic FDA data

THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal

Manufacturer
THERAPLEX, LLC | Pure Source, LLC
Effective date
2025-06-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:11

Label at a glance#

ProductTHERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal
Active ingredientOATMEAL
Label structure8 sections

Indications and uses

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

Dosage and administration

apply as needed, or as directed by your doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed, or as directed by your doctor.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature
  • keep from freezing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cyclomethicone, ozokerite wax, petrolatum (special fraction)

Questions?

OTC - QUESTIONS SECTION

email help@theraplex.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82280-618-00THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal85.05 g in 1 JARCREAM85.051

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82280-61882280-618-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONENMQ347994ZIACT
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UIACT
OATMEAL8PI54V663YACTIB

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
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal OatmealOATMEALTHERAPLEX, LLCe51aa467-ffe7-4c6b-8588-6df8592596d42025-06-16WarningsExact identifier
ndc (package): 82280-618-00
ndc (product): 82280-618
ndc11 (package): 82280061800
spl id: 375d2a1b-2049-cb83-e063-6394a90ae202
spl set id: e51aa467-ffe7-4c6b-8588-6df8592596d4

Reported adverse events (FAERS/openFDA)#

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