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Product NDC Code | 84711-002 | ||||
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Drug Name | Puriya eczema cream |
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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 | IPC Republic, Inc. | ||||
Packages |
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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: •Test a small area on your skin to check for any potential allergic reaction •apply as needed to affected area •for children under 3 months of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Glycerin*, Glyceryl Stearate SE*, Propanediol*, Persea Gratissima (Avocado) Oil, Cetearyl Olivate, Squalane, Sorbitan Olivate, Simmondsia Chinensis (Jojoba) Seed Oil, Avena Sativa (Oat) Kernel Oil, Cetyl Palmitate*, Ascorbyl Palmitate, Bisabolol, Glyceryl Caprylate*, Levulinic Acid, Oenothera Biennis (Evening Primrose) Oil, Sodium Hyaluronate*, Tocopherol*, Sodium Anisate, Xanthan Gum, Sodium Hydroxide, Phytic Acid, Ceramide NP, Avena Sativa (Oat) Kernel Extract, Centella Asiatica (Gotu Kola) Extract, Calendula Officinalis (Calendula) Flower Extract. *From natural origins
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: •eczema •rash
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.Puriya Eczema Cream Colloidal Oatmeal EVENING PRIMROSE OIL XANTHAN GUM OATMEAL OATMEAL ALOE VERA LEAF SUNFLOWER OIL HYALURONATE SODIUM TOCOPHEROL GLYCERYL CAPRYLATE LEVULINIC ACID SORBITAN OLIVATE GLYCERIN AVOCADO OIL JOJOBA OIL ASCORBYL PALMITATE SODIUM ANISATE OAT CALENDULA OFFICINALIS FLOWER SODIUM HYDROXIDE CERAMIDE NP WATER CETEARYL OLIVATE CETYL PALMITATE GLYCERYL STEARATE SE PROPANEDIOL SHEA BUTTER OAT KERNEL OIL LEVOMENOL FYTIC ACID CENTELLA ASIATICA LEAF SQUALANE
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.puriya ® ECZEMA CREAM RELIEVES DRY, ITCHY, IRRITATED SKIN FOR ULTRA SENSITIVE SKIN SKIN PROTECTANT: COLLOIDAL OATMEAL ALOE VERA EVENING PRIMPROSE SHEA BUTTER OAT KERNEL HYALURONIC ACID GOTU KOLA CALENDULA FLOWER +4 MORE PLANTS Net wt. 4.0 oz / 113g label label pt 2 label pt 3
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.Drug Facts
Other information Store below 78°F (25°C)
Distributed by: IPC Republic, Inc. DBA Puriya Irvine, CA 92614 [email protected] www.puriya.com Made in USA from domestic and global sources
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 immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Comments? 844-234-1476
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 doctor if •condition worsens •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.Warnings For external use only When using this product •Do not get into eyes Stop use and ask 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 •If swallowed, get medical help or contact a Poison Control Center immediately.
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