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Product NDC Code | 71131-200 | ||||
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Drug Name | Kivoria skin protectant |
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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 | UBER SCIENTIFIC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.DRUG FACTS ACTIVE INGREDIENT Colloidal Oatmeal PURPOSE Skin protectant
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Allantoln, Beeswax, Banzyl Alcohol, Cetyl Alchohol, Chamomllla Racutlta (Chamomille) Extract, Cucumis S11tiv11s (Cucumber) Fruit Extract, deionized W,iter, Echin,.cee Angustifolie (Coneflower) Extrect, Glyceryl Steerete, Glycyrrhlze Glebre (Licorice) Extrect, Hellenthus Annus (Sunflower) Oil, Lanolin, Paraffin Wax, PEG-100 Stearate, Prunus Amygdelus Oulcis (Sweet Almond) Oil, Simmondsie Chinensis (Jojobe) Oil, Steerlc Acid, Tocopheryl Acet8te (Vltemln E), Trlethenolemlne.
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.USE Temporarily protects and helps relieve minor skin irritation and itching due to eczema and 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.KIVORIA SKIN PROTECTANT COLLOIDAL OATMEAL OATMEAL OATMEAL ALLANTOIN BENZYL ALCOHOL CETYL ALCOHOL ALPHA-TOCOPHEROL LANOLIN JOJOBA OIL GLYCERYL STEARATE/PEG-100 STEARATE GLYCYRRHIZA GLABRA WHITE WAX CHAMOMILE CUCUMBER FRUIT OIL WATER ECHINACEA ANGUSTIFOLIA LEAF PARAFFIN STEARIC ACID TROLAMINE ALMOND OIL SUNFLOWER OIL
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.PDP KIVORIA SKIN CARE SKIN PROTECTANT CREAM WITH COLLOIDAL OATMEAL 5OZ | 143G PDP DFP
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION Store at room temperature Avoid Direct Sunlight Distributed By: UberScientific LLC 3211 Vineland Rd STE 250 Kissimmee, FL 34747
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 consult physician if condition worsens, if symptoms last for more than 7 days or if symptoms clear up and occur again within a few days.
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. Keep out of eyes when using. Keep out of reach of children Stop use and consult physician if condition worsens, if symptoms last for more than 7 days or if symptoms clear up and occur again within a few days.
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