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| Product NDC Code | 49449-100 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tcx skincare |
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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 | 1189915 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | Theraceutix, LLC | ||||||
| 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 2%
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 to affected areas of skin twice daily
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Cetyl Palmitate, Dimethicone, DMDM Hydantoin, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Mineral Oil, Octyldodecanol, PEG-40 Stearate, Phenoxy Ethanol, Sodium Hydroxide, 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 helps relieve minor skin irritation and itching due to dry skin and eczema
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.TCX Skincare Colloidal Oatmeal OATMEAL OATMEAL WATER GLYCERIN CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) CETYL PALMITATE MINERAL OIL MEDIUM-CHAIN TRIGLYCERIDES CETYL ALCOHOL GLYCERYL 1-STEARATE DIMETHICONE PEG-40 STEARATE SODIUM HYDROXIDE PHENOXYETHANOL DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE OCTYLDODECANOL
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.Package/Label Principal Display Panel - Carton Label ECZEMA AND DRY SKIN RELIEF Skin Protectant tcx skincare ® UNIQUE HYDROMIMETICS ™ 2 fl oz/59 mL Carton Label image-01
Package/Label Principal Display Panel - Sample Label tcx skincare ® UNIQUE HYDROMIMETICS ™ 0.3 oz Eczema and Dry Skin Relief Skin Protectant Directions: Apply to affected areas of skin twice daily SAMPLE NOT FOR RESALE tcxskincare.com Sample Label image-02
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.
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 • Stop use and ask doctor if condition worsens
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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product: • Do not get into eyes • Stop use and ask doctor if condition worsens
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