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| Product NDC Code | 84293-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Whipped gel |
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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 | GEL | ||||
| Application Number | M016 | ||||
| Labeler Name | OCEAN OLIVE 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.Colloidal Oatmeal 0.1%
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Cetearyl Olivate, Sorbitan Olivate, Butyspermum Parkii (Shea) Butter, Sodium Acrylates Copolymer, Glycerin, Inulin, Fucus Vesiculosis (Bladderwrack) Extract, Cetyl Palmitate, Sorbitan Palmitate, Lecithin, Allantoin, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Lactic Acid, Sclerotium Gum, Cyanocobalamin, Pullulan, Silica.
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.temporarily protects and helps relieve minor skin irritation and itching due to eczema
Purpose
Information about the drug product’s indications for use.Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Whipped Gel Colloidal Oatmeal CETEARYL OLIVATE SORBITAN OLIVATE FUCUS VESICULOSUS SORBITAN MONOPALMITATE LACTIC ACID SUNFLOWER OIL SHEA BUTTER ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) INULIN PHENOXYETHANOL CETYL PALMITATE LECITHIN, SOYBEAN XANTHAN GUM BETASIZOFIRAN PULLULAN WATER PROPANEDIOL GLYCERIN SILICON DIOXIDE ALLANTOIN ETHYLHEXYLGLYCERIN CYANOCOBALAMIN 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.Ocean Olive Whipped Gel
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Mislabeled section
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.OCEAN OLIVE Whipped Gel Nourishing Eczema Spot Treatment Skin Protectant Accepted National Eczema Association 1.7 oz / 50 ml
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 or comments? Call toll free 1-800-484-9354 M-F 8am-5pm CST www.ocean-olive.com
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 a doctor if conditions worsen symptoms last more than 7 days or clear up and occur again within a few days
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.
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.For external use only. When using this product do not get into eyes. Stop use and consult a doctor if conditions worsen symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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