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| Product NDC Code | 52915-010 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | 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/SHAMPOO | ||||||||
| RxCUI drug identifier | 1437616 | ||||||||
| Application Number | part347 | ||||||||
| Labeler Name | ORGANIC & SUSTAINABLE BEAUTY | ||||||||
| 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.Other information You may report a serious adverse reaction event from using this product to: 5933 Bowcroft St. Los Angeles, CA 90016
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 dispense a dime-to-quarter sized amount into palm, massage into wet hair starting at the scalp and working to the ends. Rinse. for extra cleansing, allow to sit for 30 seconds and then rinse.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, decyl glucoside, lauryl glucoside, quillaja saponaria bark extract, glycerine, allantoin, calendula officinalis flower extract, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil, hydrolyzed quinoa, xanthan gum, panthenol, phytic acid, gluconolactone, 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 and itching due to: Rashes Eczema Poison ivy, oak, or sumac Insect bites
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 OATMEAL OATMEAL OATMEAL Water decyl glucoside lauryl glucoside quillaja saponaria bark glycerin allantoin calendula officinalis flower VIOLA TRICOLOR WHOLE yucca schidigera root aloe vera leaf jojoba oil quinoa oil xanthan gum panthenol fytic acid gluconolactone sodium benzoate
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 - 562 mL Bottle Label CALIF♥RNIA BABY ® TRUSTED SINCE 1995 eczema therapy SHAMPOO & BODYWASH SKIN PROTECTANT GLUTEN FREE + STEROID FREE GENTLE • NON-DRYING • NO ADDED FRAGRANCE BABIES + KIDS + ADULTS ALLERGY TESTED © 2019 562 mL/19 fl. oz. Principal Display Panel - 562 mL Bottle 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
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 Poison Control within the U.S. (1-800-222-1222)
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 patch test before use keep out of eyes clean with soap and water to remove to avoid slipping, use mat in tub or shower
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 External use only. When using this product patch test before use keep out of eyes clean with soap and water to remove to avoid slipping, use mat in tub or shower 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 Poison Control within the U.S. (1-800-222-1222)
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