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| Product NDC Code | 59062-1303 | ||||
|---|---|---|---|---|---|
| Drug Name | Babyganics eczema |
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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 | ||||
| RxCUI drug identifier | 240464 | ||||
| Application Number | part347 | ||||
| Labeler Name | KAS Direct LLC dba BabyGanics | ||||
| 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 massage into baby's skin, especially after bathing - perfect for face and body for use on mild to moderate eczema or as directed by a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, butyrospermum parkii (shea) butter, cetearyl alcohol, cetyl alcohol, isopropyl palmitate, glycerin, glyceryl stearate, theobroma cacao (cocoa) seed butter, hydrolyzed oats, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil, cetearyl glucoside, tocopherol, glyceryl dilaurate, caprylyl glycol, xanthan gum, sodium phytate, ethylhexylglycerin, citric acid, sodium hydroxymethylglycinate
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: rashes eczema
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.BABYGANICS ECZEMA OATMEAL OATMEAL OATMEAL WATER SHEA BUTTER CETOSTEARYL ALCOHOL CETYL ALCOHOL ISOPROPYL PALMITATE GLYCERIN GLYCERYL MONOSTEARATE COCOA BUTTER OAT NIGELLA SATIVA SEED OIL CARROT SEED OIL CHIA SEED OIL RASPBERRY SEED OIL CRANBERRY SEED OIL CETEARYL GLUCOSIDE TOCOPHEROL GLYCERYL DILAURATE CAPRYLYL GLYCOL XANTHAN GUM PHYTATE SODIUM ETHYLHEXYLGLYCERIN CITRIC ACID MONOHYDRATE SODIUM HYDROXYMETHYLGLYCINATE
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 DISPLAY PANEL - 85 g Tube Label extra soothing babyganics ® eczema care skin protectant cream with colloidal oatmeal ∙ relieves dry, itchy, irritated skin ∙ non–allergenic pediatrician & dermatologist tested no: cortisone, steroids, parabens, sulfates, phthalates or fragrances + NeoNourish* Natural Seed Oil Blend 3 OZ (85g) Principal Display Panel - 85 g Tube Label
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
Dist. by: KAS Direct, LLC. Hicksville, NY 11801
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 within 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
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature 59-77°F (15-25°C)
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 do not get into eyes 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. If swallowed, get medical help or contact a Poison Control Center right away.
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