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| Product NDC Code | 61328-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Eczema hand 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 | 240651 | ||||
| Application Number | M016 | ||||
| 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 INGREDIENT Colloidal Oatmeal 1%
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 hands.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water/Eau/Aqua, Vegetable Oil/Huile Végétale, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Stearyl Alcohol, Glyceryl Stearate, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Jojoba Oil/Macadamia Seed Oil Esters, Annona Cherimola Fruit Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Helianthus Annuus (Sunflower) Extract, Allantoin, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Phytosteryl Macadamiate, Amylopectin, Phytosterols, Lecithin, Acetyl Glutamine, Lithothamnion Calcareum Extract, Folic Acid, Bacillus/Soybean Ferment Extract, Oligopeptide-3, Sodium Hyaluronate, Oligopeptide-2, Oligopeptide-1, Hexapeptide-11, Lactic Acid, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Ceramide EOP, Xanthan Gum, Potassium Sorbate, Trisodium Ethylenediamine Disuccinate, Citric Acid, Ethylhexylglycerin, Sodium Citrate, Propanediol, Pentylene Glycol, Phenylpropanol, Sodium Dehydroacetate, Caprylyl Glycol, Sodium Lauroyl Lactylate, Sodium Benzoate, Carbomer, Phenoxyethanol
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 rashes or 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.ECZEMA HAND RELIEF COLLOIDAL OATMEAL HELIANTHUS ANNUUS SEED WAX ETHYLHEXYLGLYCERIN CITRIC ACID MONOHYDRATE AMYLOPECTIN, UNSPECIFIED SOURCE CAPRYLYL CAPRYLATE/CAPRATE RICE GERM XANTHAN GUM COCONUT OIL JOJOBA OIL CERAMIDE NP CERAMIDE 1 MACADAMIA SEED OIL GLYCERETH-8 ESTERS PHYTOSTERYL MACADAMIATE ACEGLUTAMIDE PHENYLPROPANOL LACTIC ACID PHYMATOLITHON CALCAREUM OATMEAL OATMEAL WATER POLYGLYCERYL-2 STEARATE STEARYL ALCOHOL GLYCERYL MONOSTEARATE PHENOXYETHANOL POTASSIUM SORBATE SODIUM CITRATE LECITHIN, SOYBEAN HEXAPEPTIDE-11 TOCOPHEROL CAPRYLYL GLYCOL GLYCERIN SUNFLOWER OIL CHERIMOYA SUNFLOWER SEED TRISODIUM ETHYLENEDIAMINE DISUCCINATE ALLANTOIN ROSEMARY PROPANEDIOL PENTYLENE GLYCOL SODIUM DEHYDROACETATE FOLIC ACID HYALURONATE SODIUM SODIUM LAUROYL LACTYLATE SODIUM BENZOATE CERAMIDE AP PHYTOSPHINGOSINE CHOLESTEROL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES SQUALENE
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
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? 1.866.927.2783
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
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. if contact occurs, rinse thoroughly with water.
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