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| Product NDC Code | 69366-503 | ||
|---|---|---|---|
| Drug Name | Honest eczema 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 | OINTMENT | ||
| RxCUI drug identifier | 1545142 | ||
| Application Number | M016 | ||
| Labeler Name | The Honest Company, Inc. | ||
| 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. Safe to use every day on baby's sensitive skin.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Water (Aqua), Carthamus Tinctorius (Safflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Coco-Caprylate/Caprate, Disteardimonium Hectorite, Propanediol, Bambusa Arundinacea Stem Extract, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-3 Diisostearate, Magnesium Sulfate, Polyglyceryl-6 Polyricinoleate, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Pyrus Malus (Apple) Fruit Extract, Isosorbide Disunflowerseedate, Aloe Barbadensis Leaf Juice, Alpha-Glucan Oligosaccharide, Glycerin, Squalane, Allantoin, Tocopherol, 1,2-Hexanediol, Caprylhydroxamic Acid, Trisodium Ethylenediamine Disuccinate, Potassium Sorbate, Sodium Benzoate
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 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.Honest Eczema Balm Colloidal Oatmeal WATER SAFFLOWER OIL OLIVE OIL YELLOW WAX COCO-CAPRYLATE/CAPRATE DISTEARDIMONIUM HECTORITE PROPANEDIOL BAMBUSA BAMBOS STEM POLYGLYCERYL-3 RICINOLEATE MAGNESIUM SULFATE, UNSPECIFIED FORM SHEA BUTTER COCONUT OIL APPLE ALOE VERA LEAF .ALPHA.-GLUCAN OLIGOSACCHARIDE GLYCERIN SQUALANE ALLANTOIN TOCOPHEROL 1,2-HEXANEDIOL CAPRYLHYDROXAMIC ACID TRISODIUM ETHYLENEDIAMINE DISUCCINATE POTASSIUM SORBATE SODIUM BENZOATE 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.Package/Label Principal Display Panel - Carton H O N E S T ® soothe™ ADVANCED ECZEMA RELIEF BALM FRAGRANCE FREE Instant relief from dry, itchy skin Prebiotics + colloidal oatmeal Skin Protectant NET WT 3.0 oz (85.0 g) HOW TO USE ME : Made with care for flare-ups! Apply my steroid-free, hypoallergenic balm anytime for instant itch relief from dry, irritatated skin. Clinically tested to be safe for baby, I'm made with prebiotics to nourish the good bacteria, aka your skin's bodyguard. Made in the USA with US and imported materials. © 2023 Distributed by The Honest Company, Inc., 12130 Millennium DR #500 Los Angeles, CA 90094 HONEST.COM•888-862-8818 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
Other information: Store at room temperature.
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 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 use and ask a doctor if condition worsens or 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.
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 or 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 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