FDA.reportPublic FDA data

Satya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF

Manufacturer
Satya Organic Inc. | Vegewax Candleworx Ltd
Effective date
2023-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:24

Label at a glance#

ProductSatya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF
Active ingredientOATMEAL
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Colloidal oatmeal 1%

OTC - PURPOSE SECTION

Purpose

Skin protectant

INDICATIONS & USAGE SECTION

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

• rashes • eczema • poison ivy, oak or sumac • insect bites

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product do not get into eyes

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 a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

apply as needed

INACTIVE INGREDIENT SECTION

InactiveingredientsBeeswax*, Calendula Flower Oil*, Jojoba Oil*, Sweet Almond Oil.*

* USDA certified organic ingredient.

SPL UNCLASSIFIED SECTION

Questions? 778.655.9006

@SATYAORGANIC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Satya

ORGANIC

FRAGRANCE-FREE

ECZEMABoxBox

RELIEF

Skin Protectant Balm

Temporarily protects and helps relieve minor skin irritations and itching due to:

eczema ♦ rashes ♦ insect bites ♦ poison ivy, oat or sumac

Colloidal Oatmeal 1%

USDA Certified Organic    NDC 82590-030-01

NET CONTETNS 1 FL OZ (30 ML) BALM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1545142colloidal oatmeal 1 % Topical OintmentPSN2
1545142colloidal oatmeal 0.01 MG/MG Topical OintmentSCD2
1545142colloidal oatmeal 1 % Topical OintmentSY2

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
82590-030-012025-01-30C16284748780-12cef2736-6d93-d83d-e063-dadaa90ab31fSatya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82590-030-01Satya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF30 mL in 1 TUBEOINTMENT302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82590-030SATYA ORGANIC FRAGRANCE-FREE ECZEMA RELIEF (COLLOIDAL OATMEAL) OINTMENT [SATYA ORGANIC INC.]2Legacy NDC, 1 package rows20230121_9b724430-20d1-4081-b7f5-f5732595dd02.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82590-03082590-030-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
SYNTHETIC BEESWAX08MNR5YE2RIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
JOJOBA OIL724GKU717MIACT
ALMOND OIL66YXD4DKO9IACT

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
b9a60e34-a82e-4c24-ab36-298d92e9ce6f9b724430-20d1-4081-b7f5-f5732595dd022023-01-16WarningsExact identifier
spl id: b9a60e34-a82e-4c24-ab36-298d92e9ce6f
spl set id: 9b724430-20d1-4081-b7f5-f5732595dd02

Reported adverse events (FAERS/openFDA)#

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