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Product NDC Code | 71570-001 | ||||
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Drug Name | Atopis eczema therapy cream |
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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 | 1654149 | ||||
Application Number | part347 | ||||
Labeler Name | Bionona Limited | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Colloidal Oatmeal 0.5%
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.Apply twice daily for best results.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Myriphytase extract (Cocos nucifera (coconut) water, Bee pollen, Cocos nucifera coconut) oil, Notofagus fuca honeydew), Cetearyl olivate, Sorbitan olivate, Carthamus tinctorius (Safflower) seed oil, Cetearyl alcohol, Glycerin, Macadamia ternifolia seed oil, Butyrospermum parkii (shea butter), Tocopheryl acetate, Sodium stearoyl glutamate, benzyl alcohol, dehydracetic acid, Citrus aurantium bergamia (bergamot) fruit oil, Xanthan gum, Citric acid.
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.temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema • insect bites
Purpose
Information about the drug product’s indications for use.Colloidal Oatmeal 0.5%...... Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Atopis Eczema Therapy Cream Colloidal Oatmeal COCONUT WATER BEE POLLEN HONEYDEW MELON SAFFLOWER OIL DEHYDROACETIC ACID BERGAMOT OIL XANTHAN GUM OATMEAL OATMEAL COCONUT OIL CETEARYL OLIVATE SORBITAN OLIVATE CETOSTEARYL ALCOHOL GLYCERIN MACADAMIA OIL SHEA BUTTER ALPHA-TOCOPHEROL ACETATE BENZYL ALCOHOL ANHYDROUS CITRIC ACID 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.ATOPIS Eczema Therapy Cream Skin Protectant Cream for eczema, rash and insect bite relief Clinically shown to relieve and protect dry, itchy, irritated skin, due to eczema • Soothes, nourishes and restores moisture • No parabens, no solvents, no artificial fragrances • Clinically trialed on humans, not tested on animals Product of New Zealand E Net Wt 2.6 oz/75g Atopis
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.(855) 969-5002 or [email protected]
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.• Safe for the face and body. • External use only. If irritation should occur discontinue use. • When using this product you may notice a slight tingling sensation; this is normal and will subside. • Do not use if quality seal is broken or missing.
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.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