FDA.reportPublic FDA data

pediadermics eczema 3

Manufacturer
Renu Laboratories, LLC
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:19:28

Label at a glance#

ProductPediadermics eczema 3
Active ingredientDIMETHICONE, OATMEAL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Colloidal oatmeal 0.1%

Dimethicone 2%

OTC - PURPOSE SECTION

Purpose

Skin protectant

Skin protectant

INDICATIONS & USAGE SECTION

Uses

Temporarily protects sensitive skin and helps relieve minor skin irritation due to eczema. Temporarily helps prevent and relieve chapped or cracked skin.

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product

  • Do not get into eyes
  • Do not apply before bathing or showering

OTC - STOP USE SECTION

Stop use and ask a doctor if

Condition worsens

  • Symptoms last more than 2 weeks 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

For best results, follow the rule of "3"

  • Apply liberally to skin at least "3" times a day
  • Apply within "3" minutes of bathing
  • Keep a "3" location supply (Home, On-the-Go and School) !

INACTIVE INGREDIENT SECTION

Inactive Ingredients

1,2 Hexanediol, Ascorbyl Palmitate, Bio-Saccharide 1, Candelilla / Jojoba / Rice bran, Polyglyceryl-3 Esters, Glyceryl Stearate, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Caprylyl Glycol, Glycerin, Caprylhydroxamic Acid, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cetyl Alcohol, Cholesterol, Deionized Water, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Niacinamide, Ophiopogon Japonicus Root Extract, Maltodextrin, Phytosphingosine, Propanediol, Saccharide Isomerate, Sodium EDTA, Sodium Hyaluronate, Sodium PCA, Stearic Acid, Tocopherol, Xanthan Gum

OTHER SAFETY INFORMATION

Other information

Store at room temperature.

OTC - QUESTIONS SECTION

Questions?

pediadermics@gmail.com

STATEMENT OF IDENTITY SECTION

eczema 3

skin barrier repair cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eczema 3 Tube ArtEczema 3 Tube Art

ECZEMA 3 tube artwork

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-580-062025-04-18C16284748780-12cef2736-6a81-d83d-e063-dadaa90ab31fPediadermics eczema 3
76348-580-062025-01-30C16284748780-12cef2736-6a81-d83d-e063-dadaa90ab31fPediadermics eczema 3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-580-06Pediadermics eczema 3168 g in 1 TUBECREAM1684

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-58076348-580-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEADOWFOAM SEED OIL412ZHA4T4YIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
CERAMIDE 15THT33P7X7IACT
JOJOBA OIL724GKU717MIACT
DIMETHICONE92RU3N3Y1OACTIB
RICE BRANR60QEP13ICIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
OATMEAL8PI54V663YACTIB
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CANDELILLA WAXWL0328HX19IACT
PROPANEDIOL5965N8W85TIACT
NIACINAMIDE25X51I8RD4IACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
PALMITIC ACID2V16EO95H1IACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
CHOLESTEROL97C5T2UQ7JIACT
CERAMIDE NP4370DF050BIACT
POLYGLYCERIN-34A0NCJ6RD6IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CERAMIDE APF1X8L2B00JIACT
EDETATE DISODIUM7FLD91C86KIACT
HEXANEDIOLZIA319275IIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYALURONATE SODIUMYSE9PPT4THIACT
OATZ6J799EAJKIACT
MALTODEXTRIN7CVR7L4A2DIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
OPHIOPOGON JAPONICUS ROOT90PS6JV9GZIACT

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
Pediadermics eczema 3COLLOIDAL OATMEAL, DIMETHICONERenu Laboratories, LLCaf861f0b-4387-6861-e053-2995a90a8bfa2025-12-02WarningsExact identifier
ndc (package): 76348-580-06
ndc (product): 76348-580
ndc11 (package): 76348058006
spl id: 44fe1bad-8844-9960-e063-6394a90a8a7a
spl set id: af861f0b-4387-6861-e053-2995a90a8bfa

Reported adverse events (FAERS/openFDA)#

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