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| Product NDC Code | 76348-585 | ||||
|---|---|---|---|---|---|
| Drug Name | Pediadermics eczema 2 |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 317564 | ||||
| Application Number | part348 | ||||
| Labeler Name | RENU LABORATORIES, INC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Hydrocortisone 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: For the temporary relief of minor skin irritations, inflammation and rashes due to eczema
Purpose
Information about the drug product’s indications for use.Purpose Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.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 HYDROCORTISONE HYDROCORTISONE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.BOTTLE ARTWORK BOTTLE ART
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Dosage and Administration - NO Major Changes at all
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if Condition worsens or irritation occurs Symptoms last more than 2 weeks
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API