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| Product NDC Code | 57337-101 | ||||
|---|---|---|---|---|---|
| Drug Name | Eczema care moisturizing 3 oz. |
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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 | LOTION | ||||
| Application Number | part347 | ||||
| Labeler Name | Rejoice International 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% Purpose Skin protectant
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, Petrolatum, Cetearyl Alcohol, Dimethicone, Isopropyl Myristate, Distearyldimonium Chloride, Steareth-2, Avena Sativa (Oat) Kernel Extract, Phenoxyethanol, Steareth-21, Sodium Chloride, Benzalkonium Chloride, Panthenol, Ceramide NP, Avena Sativa (Oat) Kernel Oil
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 itching and irritation 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 Care Moisturizing 3 oz. Colloidal Oatmeal WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE PANTHENOL PETROLATUM ISOPROPYL MYRISTATE CETYL ALCOHOL DIMETHICONE OAT KERNEL OIL STEARETH-20 OAT BENZALKONIUM CHLORIDE CERAMIDE NP SODIUM CHLORIDE OATMEAL OATMEAL PHENOXYETHANOL STEARETH-2 CETOSTEARYL ALCOHOL
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.Label copy label
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. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
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 using this product and ask a doctor if condition worsens, or if symptoms last more than 7 days, or if they clear up and occur again within a few days. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
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 contact with eyes. In case of eye contact, flush with water. Stop using this product and ask a doctor if condition worsens, or if symptoms last more than 7 days, or if they clear up and occur again within a few days. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature.
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. When using this product avoid contact with eyes. In case of eye contact, flush with water. Stop using this product and ask a doctor if condition worsens, or if symptoms last more than 7 days, or if they clear up and occur again within a few days. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
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