Statement Of Identity
pediadermics Eczema 2 flare control spray
Manufactured for Pediadermics LLC
Bethlehem PA 18018
www.pediadermics.com
Pediadermics Eczema 2 Spray
FDA Label NDC 76348-585
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Pediadermics Eczema 2 (NDC 76348-585). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding statement of identity, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients:
Hydrocortisone 1%
Otc - Purpose
Purpose
Anti-itch
Indications & Usage
Uses:
For the temporary relief of minor skin irritations, inflammation and rashes due to eczema
Warnings
Warnings For external use only
Otc - When Using
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
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
Keep out of reach of children
- If swallowed get medical help or contact a Poison Control Center right away
Dosage & Administration
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
Dosage and Administration - NO Major Changes at all
Inactive Ingredient
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
Package Label.Principal Display Panel
BOTTLE ARTWORK
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