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| Product NDC Code | 64760-777 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Avene xeracalm eczema calming relief balm |
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| Type | Brand | ||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 240651 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | Pierre Fabre USA 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 ingredient Colloidal oatmeal 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 Apply as needed. For targeted areas on body, face and hands.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (aqua), Propanediol, Caprylic/capric triglyceride, Glyceryl stearate, Cetearyl alcohol, Cetyl alcohol, Glycerin, 1,2 Hexanediol, Arginine, Caprylyl glycol, Ceramide NP, Citric acid, Maltodextrin, Oenothera biennis (evening primrose) oil, Ophiopogon japonicus root extract, Polyacrylate-13, Polyisobutene, Polysorbate 20, Sodium benzoate, Sodium hydroxide, Sorbitan isostearate, Tocopherol.
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 Temporarily protects and helps relieve minor skin irritation and itching due to: Eczema Rashes
Purpose
Information about the drug product’s indications for use.Purpose Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Avene XERACALM Eczema Calming Relief Balm Colloidal oatmeal POLYSORBATE 20 SORBITAN ISOSTEARATE SODIUM BENZOATE 1,2-HEXANEDIOL WATER OATMEAL OATMEAL CETOSTEARYL ALCOHOL ARGININE CAPRYLYL GLYCOL PROPANEDIOL GLYCERYL MONOSTEARATE CETYL ALCOHOL GLYCERIN ACONITIC ACID MALTODEXTRIN EVENING PRIMROSE OIL POLYACRYLATE-13 POLYISOBUTYLENE (1000 MW) OPHIOPOGON JAPONICUS ROOT TOCOPHEROL CERAMIDE NP SODIUM HYDROXIDE MEDIUM-CHAIN TRIGLYCERIDES
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.Tube 337123 Tube 337123
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days
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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-41-AVENE (28363).
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 When using this product - do not get into eyes
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