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| Product NDC Code | 61328-112 | ||||
|---|---|---|---|---|---|
| Drug Name | Eczema dermatitis relief balm |
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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 | 1595494 | ||||
| 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 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.DIRECTIONS Apply as needed to face and body.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water/Aqua/Eau, Glycerin, Annona Cherimola Fruit Extract, Jojoba Oil/Macadamia Seed Oil Esters, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Coco-Caprylate/Caprate, Sorbitan Olivate, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Octyldodecanol, Triheptanoin, Allantoin, Zinc Oxide, Squalene, Helianthus Annuus (Sunflower) Seed Wax, Phytosteryl Macadamiate, Phytosterols, Lecithin, Acetyl Glutamine, Castanea Sativa (Chestnut) Leaf Extract, Ceramide NP, Amylopectin, Chlorophyllin-Copper Complex, Phytosphingosine, Ceramide AP, Cholesterol, Folic Acid, Hexapeptide-11, Oligopeptide-1, Oligopeptide-2, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Oligopeptide-3, Tocopherol, Lithothamnion Calcareum Extract, Ceramide EOP, Carbomer, Sodium Stearoyl Glutamate, C9-12 Alkane, Polyurethane-100, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Caprylic/Capric Triglyceride, Sodium Lauroyl Lactylate, Sodium Hydroxide, Sodium Citrate, Propanediol, Polyhydroxystearic Acid, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Citric Acid, Xanthan Gum, Lactic Acid, Sodium Carbonate, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, 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 DERMATITIS RELIEF BALM COLLOIDAL OATMEAL SODIUM CITRATE POLYHYDROXYSTEARIC ACID (2300 MW) AMYLOPECTIN, UNSPECIFIED SOURCE PHENYLPROPANOL PHYTOSTERYL MACADAMIATE POTASSIUM SORBATE SODIUM CHLORIDE SODIUM CARBONATE SODIUM BENZOATE MACADAMIA SEED OIL GLYCERETH-8 ESTERS HEXYLENE GLYCOL LECITHIN, SOYBEAN GLYCERIN GLYCERYL MONOSTEARATE SHEA BUTTER HELIANTHUS ANNUUS SEED WAX PENTYLENE GLYCOL PHYTOSPHINGOSINE HYALURONATE SODIUM TOCOPHEROL PHYMATOLITHON CALCAREUM CETOSTEARYL ALCOHOL COCO-CAPRYLATE/CAPRATE SORBITAN OLIVATE OCTYLDODECANOL SQUALANE SODIUM STEAROYL GLUTAMATE ZINC OXIDE SODIUM LAUROYL LACTYLATE MEDIUM-CHAIN TRIGLYCERIDES SODIUM HYDROXIDE PROPANEDIOL CASTANEA SATIVA LEAF SODIUM COPPER CHLOROPHYLLIN SODIUM DEHYDROACETATE HEXAPEPTIDE-11 LACTIC ACID CERAMIDE 1 OATMEAL OATMEAL WATER TRIHEPTANOIN ALLANTOIN SQUALENE CAPRYLYL GLYCOL CHOLESTEROL XANTHAN GUM ETHYLHEXYLGLYCERIN CETEARYL OLIVATE SUNFLOWER OIL PHENOXYETHANOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ACEGLUTAMIDE CERAMIDE NP CERAMIDE AP FOLIC ACID CITRIC ACID MONOHYDRATE CHERIMOYA
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