FDA.reportPublic FDA data

Serawise Eczema Rescue Cream

Manufacturer
DrAnaMaria.com LLC
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:49:21

Label at a glance#

ProductSerawise Eczema Rescue
Active ingredientOATMEAL
Label structure7 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching duee to: rashes eczema poison ivy, oak, or sumac  insect bites

Dosage and administration

Apply as Needed

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 relieve minor skin irritation and itching duee to:

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes.

Stop use and consult 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as Needed

Other Information

SPL UNCLASSIFIED SECTION

Keep away from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Ceteareth-20, Cetearyl Alcohol, Cyanocobalamin (VitB12), Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hypericum Perforatum Leaf Extract, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Sodium Benzoate, Water (Aqua).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label.jpgOuter Label.jpgInner Label.jpgInner Label.jpg

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85050-575-00Serawise Eczema Rescue1 in 1 BOXCREAM11
85050-575-00Serawise Eczema Rescue118.29 mL in 1 JARCREAM118.291

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85050-575SERAWISE ECZEMA RESCUE (OATMEAL) CREAM [DRANAMARIA.COM LLC]1Current NDC, 2 package rows20241228_e805866a-2349-4b86-bc83-a7c859cb9403.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85050-57585050-575-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BEESWAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
CALCIUM GLUCONATESQE6VB453KIACT
CETEARETH-20YRC528SWUYIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CYANOCOBALAMINP6YC3EG204IACT
DIMETHICONE92RU3N3Y1OIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE230OU9XXE4IACT
HYPERICUM PERFORATUM LEAFDOC7OB843YIACT
PEG-100 STEARATEYD01N1999RIACT
PERSEA GRATISSIMA (AVOCADO) OIL6VNO72PFC1IACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
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
Serawise Eczema RescueOATMEALDrAnaMaria.com LLCe805866a-2349-4b86-bc83-a7c859cb94032024-12-18WarningsExact identifier
ndc (package): 85050-575-00
ndc (product): 85050-575
ndc11 (package): 85050057500
spl id: 299514c6-0452-7bd2-e063-6294a90af9b3
spl set id: e805866a-2349-4b86-bc83-a7c859cb9403

Reported adverse events (FAERS/openFDA)#

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