FDA Label for Pediadermics Eczema 2
View Indications, Usage & Precautions
Pediadermics Eczema 2 Product Label
The following document was submitted to the FDA by the labeler of this product Renu Laboratories, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Statement Of Identity
pediadermics Eczema 2 flare control spray
Manufactured for Pediadermics LLC
Bethlehem PA 18018
www.pediadermics.com
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
* Please review the disclaimer below.
