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| Product NDC Code | 11344-965 | ||||
|---|---|---|---|---|---|
| Drug Name | Eczema soothing moisturizing cream |
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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 | Consumer Product Partners, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reaction Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593
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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, dimethicone, panthenol, Avena sativa (oat) kernel oil, steareth-20, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide
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.Eczema Soothing Moisturizing Cream Colloidal oatmeal WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL DIMETHICONE PANTHENOL OAT KERNEL OIL STEARETH-20 BENZALKONIUM CHLORIDE CERAMIDE 3 SODIUM CHLORIDE BENZYL ALCOHOL SODIUM HYDROXIDE OATMEAL OATMEAL
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.Principal panel display Swan ® ECZEMA SOOTHING MOISTURIZING CREAM colloidal oatmeal skin protectant Sooths dry skin, itchy, irritated skin from eczema Steroid-free Dermatologist tested Fragrance free Compare to Aveeno ® Eczema Therapy Moisturizing Cream* NET WT 7.3 OZ (207 g) image description
Principal panel display SIMPLY U ECZEMA SOOTHING MOISTURIZING CREAM WITH COLLOIDAL OATMEAL SKIM PROTECTANT soothes dry, ichy, & irriated skin resulting from eczema steroid-free fragrance free Compare to Aveeno® Eczema Therapy Daily Moisturizing Cream* NET WT 7.3 OZ (207 g) image description
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.Disclaimer *This product is not manufactured or distributed by Kenvue, Inc., distributor of Aveeno ® Eczema Therapy Daily Moisturizing Cream.
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 symptoms last more than 7 days or clear up and occur again withing a few days
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 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