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| Product NDC Code | 61328-119 | ||||
|---|---|---|---|---|---|
| Drug Name | Extra strength body |
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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 | part347 | ||||
| Labeler Name | Skinfix, 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 Ingredients 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 generously to affected areas, especially after bathing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Eau/Aqua, Glycerin, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Stearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Caprylyl Caprylate/Caprate, Glyceryl Stearate, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Oryza Sativa (Rice) Bran Extract, Avena Sativa (Oat) Kernel Oil, Allantoin, Xanthan Gum, Avena Sativa (Oat) Bran Extract, Potassium Sorbate, Citric Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ethylhexylglycerin, Moringa Oil/Hydrogenated Moringa Oil Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Trisodium Ethylenediamine Disuccinate, Aloe Barbadensis Leaf Juice, Tocopherol, Helianthus Annuus (Sunflower) Extract.
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 irritations and itching due to eczema rash and dermatitis.
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.EXTRA STRENGTH BODY Colloidal Oatmeal ALLANTOIN ALOE VERA LEAF AVENA SATIVA WHOLE OAT KERNEL OIL SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL CAPRYLATE/CAPRATE ANHYDROUS CITRIC ACID ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE SUNFLOWER OIL HELIANTHUS ANNUUS WHOLE MORINGA OLEIFERA SEED OIL RICE BRAN PHENOXYETHANOL POLYGLYCERYL-2 STEARATE POTASSIUM SORBATE ALMOND OIL ROSEMARY JOJOBA OIL STEARYL ALCOHOL TOCOPHEROL TRISODIUM ETHYLENEDIAMINE DISUCCINATE GRAPE SEED OIL WATER XANTHAN GUM OATMEAL OATMEAL
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 61328-119-28v2-R2
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
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 Avoid contact with 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
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, avoid contact with 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. When using this product Avoid contact with 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
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