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| Product NDC Code | 52915-120 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | CREAM | ||||||||
| RxCUI drug identifier | 240651 | ||||||||
| Application Number | part347 | ||||||||
| Labeler Name | ORGANIC & SUSTAINABLE BEAUTY | ||||||||
| 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 liberally onto desired area Reapply as needed. Children under 6 months: ask a doctor. Use in combination with our Eczema Shampoo & Bodywash.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, calendula officinalis flower extract, caprylic/capric triglyceride, cetyl alcohol, stearic acid, cetearyl olivate, sorbitan olivate, canola oil, allantoin, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, rosmarinus officinalis leaf extract, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, phytic acid, caprylhydroxamic acid, glyceryl caprylate.
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 & 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 medium-chain triglycerides cetyl alcohol stearic acid cetearyl olivate sorbitan olivate canola oil allantoin calendula officinalis flower VIOLA TRICOLOR WHOLE yucca schidigera root aloe vera leaf rosemary lavender oil clary sage oil fytic acid caprylhydroxamic acid GLYCERYL MONOCAPRYLATE
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 - 133 mL Container Label CALIF♥RNIA BABY ® TRUSTED SINCE 1995 therapeutic relief™ GLUTEN-FREE! ECZEMA CREAM SKIN PROTECTANT OATMEAL & CALENDULA HELPS HEAL & PROTECT DELICATE SKIN FOR BABIES, KIDS & SENSITIVE ADULTS ALLERGY TESTED 133 mL/4.5 fl. oz. PRINCIPAL DISPLAY PANEL - 133 mL Container 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 You may report a serious adverse reaction event from using this product to: 5933 Bowcroft St. Los Angeles, CA 90016.
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 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 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