PEDIADERMICS ECZEMA 2

Manufacturer
RENU LABORATORIES, LLC
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:19:32

Label at a glance#

ProductPEDIADERMICS ECZEMA 2
Active ingredientHYDROCORTISONE
Label structure13 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

pediadermics Eczema 2 flare control spray

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Hydrocortisone 1%

OTC - PURPOSE SECTION

Purpose

Anti-itch

INDICATIONS & USAGE SECTION

Uses:

For the temporary relief of minor skin irritations, inflammation and rashes due to eczema

WARNINGS SECTION

Warnings For external use only

OTC - WHEN USING SECTION

When using this product

  • Avoid direct contact with eyes, mouth, genitals/anus
  • Do not use for treatment of diaper rash without consulting a physician first

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Condition worsens or irritation occurs
  • Symptoms last more than 2 weeks

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 "2s" ...

  • Consult a physician before using on children under "2" years of age
  • Give the bottle at least "2" good shakes before using
  • Hold the botle about "2" inches from the skin
  • Dispense at least "2" full pump sprays onto areas of flaring (red, rough, itchy) skin
  • Cover flaring areas of skin completely plus about "2" finger-widths onto normal skin
  • Use "2" times a day for no more than "2" weeks straight.
  • Go to a physician if rash persists for more than "2" weeks

RECENT MAJOR CHANGES SECTION

Dosage and Administration - NO Major Changes at all

INACTIVE INGREDIENT SECTION

Inactive Ingredients

1, 2 Hexanediol, Avena Sativa (Oat) Kernel Extract, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Citric Acid, Deionized Water, Glycerin (Vegetal), Maltodextrin, UMF-20 Manuka Honey (20%), Ophiopogon Japonicus (Dwarf Lilyturf) Root Extract, Phytosphingosine, Sodium Citrate, Sodium Hyaluronate, Sodium Lauroyl Lactylate, Sorbitol, Xanthan Gum

STATEMENT OF IDENTITY SECTION

Manufactured for Pediadermics LLC

Bethlehem PA 18018

www.pediadermics.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLE ARTWORK

BOTTLE ARTBOTTLE ART

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317564hydrocortisone 1 % Topical SprayPSN3
317564hydrocortisone 10 MG/ML Topical SpraySCD3
317564hydrocortisone 1 % Topical SpraySY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
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da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-585-042025-04-18C16284748780-12cef2736-6249-d83d-e063-dadaa90ab31fPEDIADERMICS ECZEMA 2
76348-585-042025-01-30C16284748780-12cef2736-6249-d83d-e063-dadaa90ab31fPEDIADERMICS ECZEMA 2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-585-04PEDIADERMICS ECZEMA 2112 g in 1 BOTTLE, SPRAYSPRAY1123

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-58576348-585-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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 2HYDROCORTISONERENU LABORATORIES, LLCda840bf6-ed65-bafc-e053-2a95a90a92d52025-12-02WarningsExact identifier
ndc (package): 76348-585-04
ndc (product): 76348-585
ndc11 (package): 76348058504
spl id: 44fb0779-2a64-f2a5-e063-6294a90a33d1
spl set id: da840bf6-ed65-bafc-e053-2a95a90a92d5

Reported adverse events (FAERS/openFDA)#

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