FDA.reportPublic FDA data

Skin Soothing Cream - Nut Free

Manufacturer
Allure Labs
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:03

Label at a glance#

ProductSkin Soothing Cream - Nut Free
Active ingredientOATMEAL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Colloidal Oatmeal 1.0%

OTC - PURPOSE SECTION

Purpose: Skin Protectant

INDICATIONS & USAGE SECTION

Uses:

  • Temporarily protects and helps relieve minor skin iritation and itching due to rashes and eczema.

WARNINGS SECTION

Warning:

  • For external use only.

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 few days

OTC - WHEN USING SECTION

When using this product - do not get into eyes.

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 evenly to your skin. Apply lightly and use 1-3 times a day as needed.

INACTIVE INGREDIENT SECTION

Vitis Vinifera (Grape) Seed Oil, Honey*, Aloe Barbadensis Leaf Juice*, Beeswax, Helianthus Annus (sunflower) seed oil*, Water (Aqua), Sodium Bicarbonate, Phenoxyethanol, Potassium Sorbate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol

* Refers to Certified Organics.

OTHER SAFETY INFORMATION

Other Information:

Store Below 30ºC. (86ºF)

OTC - QUESTIONS SECTION

Questions or comments?

Call to toll free number (707) 652-3438

email: ariel@eczemahoneyco.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured for:

Eczema Honey Co, LLC

Hayward CA-94544

Skin Soothing Cream-Nut FreeSkin Soothing Cream-Nut Free

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN2
240651colloidal oatmeal 10 MG/ML Topical CreamSCD2
240651Avena sativa 1 % Topical CreamSY2
240651colloidal oatmeal 1 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4194-1Skin Soothing Cream - Nut Free113.5 g in 1 JARCREAM113.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4194SKIN SOOTHING CREAM - NUT FREE (COLLOIDAL OATMEAL) CREAM [ALLURE LABS]2Current NDC, Legacy NDC, 1 package rows20241208_b5eb48a5-e884-3bf6-e053-2a95a90abb97.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-419462742-4194-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
WATER059QF0KO0RIACT
GRAPE SEED OIL930MLC8XGGIACT
ALOE VERA LEAFZY81Z83H0XIACT
YELLOW WAX2ZA36H0S2VIACT
OATMEAL8PI54V663YACTIB
HONEYY9H1V576FHIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SUNFLOWER OIL3W1JG795YIIACT

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
Skin Soothing Cream - Nut FreeCOLLOIDAL OATMEALAllure Labsb5eb48a5-e884-3bf6-e053-2a95a90abb972024-12-05WarningsExact identifier
ndc (package): 62742-4194-1
ndc (product): 62742-4194
ndc11 (package): 62742419401
spl id: 288ed65b-ec90-58e2-e063-6294a90a7373
spl set id: b5eb48a5-e884-3bf6-e053-2a95a90abb97

Reported adverse events (FAERS/openFDA)#

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