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| Product NDC Code | 43251-4927 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Flexitol happy little bodies eczema relief |
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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 | 1595494 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | LaCorium Health USA 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 5%
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 to affected skin 2-3 times a day smooth in gently the smallest effective dose should be used patch test recommended on sensitive skin
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, calendula officinalis flower extract, cetearyl alcohol, ceteth-20, dimethicone, disodium EDTA, glycerin, glyceryl caprylate, glyceryl stearate, hydroxyacetophenone, isopropyl myristate, mineral oil, phenoxyethanol, sodium stearoyl glutamate, triethanolamine, water
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 relieves minor skin irritation and itching due to: eczema dermatitis 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.Flexitol Happy Little Bodies Eczema Relief oatmeal oatmeal OATMEAL Aloe Vera Leaf Water Carbomer Interpolymer type A (Allyl Sucrose Crosslinked) Calendula Officinalis Flower Cetostearyl Alcohol Ceteth-20 Dimethicone Edetate Disodium Glyceryl Monocaprylate Glyceryl Monostearate Glycerin Hydroxyacetophenone Isopropyl Myristate Mineral Oil Phenoxyethanol Trolamine SODIUM STEAROYL GLUTAMATE
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 - 56 g Tube Carton NDC 43251-4927-1 Flexitol ® happy little bodies™ ECZEMA RELIEF CREAM SOOTHES RASHES & FLARE-UPS Gentle Formula Skin Protectant Cream with colloidal oatmeal 5% Proud Supporter eczema association australasia eaa Net Wt. 2 oz (56 g) PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on broken skin
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call Toll Free 1-866-478-3338 [email protected] www.flexitol.com
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 If contact occurs, rinse eyes thoroughly with water. wait 15 minutes. If redness or swelling occurs, discontinue use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store between 50– 86°F in a dry place
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 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 this product do not get into eyes If contact occurs, rinse eyes thoroughly with water. wait 15 minutes. If redness or swelling occurs, discontinue use. Do not use on broken skin 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