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#
Contacts and useful links#
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
BOTTLE ARTWORK
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76348-585-04 | 2025-04-18 | C162847 | 48780-1 | 2cef2736-6249-d83d-e063-dadaa90ab31f | PEDIADERMICS ECZEMA 2 |
| 76348-585-04 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-6249-d83d-e063-dadaa90ab31f | PEDIADERMICS ECZEMA 2 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76348-585-04 | PEDIADERMICS ECZEMA 2 | 112 g in 1 BOTTLE, SPRAY | SPRAY | 112 | 3 |
Products#
Every source-derived product name is available through these pages.
- PEDIADERMICS ECZEMA 2
- Hydrocortisone
- 1,2-HEXANEDIOL
- SORBITOL SOLUTION 70%
- OAT
- SODIUM CITRATE
- HONEY
- PHYTOSPHINGOSINE
- HYALURONATE SODIUM
- CITRIC ACID MONOHYDRATE
- MALTODEXTRIN
- CHOLESTEROL
- SODIUM LAUROYL LACTYLATE
- PHENOXYETHANOL
- ETHYLHEXYLGLYCERIN
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- XANTHAN GUM
- WATER
- CERAMIDE 1
- CERAMIDE NP
- CERAMIDE AP
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76348-585 | 76348-585-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PEDIADERMICS ECZEMA 2 | HYDROCORTISONE | RENU LABORATORIES, LLC | da840bf6-ed65-bafc-e053-2a95a90a92d5 | 2025-12-02 | Warnings | 76348-585-04 76348-585 76348058504 44fb0779-2a64-f2a5-e063-6294a90a33d1 da840bf6-ed65-bafc-e053-2a95a90a92d5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
