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Product NDC Code | 72113-104 | ||||
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Drug Name | Evereden multi-purpose healing balm |
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Type | Brand | ||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | JELLY | ||||
Application Number | part346 | ||||
Labeler Name | Eden Brands Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Glycerin 20%
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. • Children under 6 months: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Ricinus Communis (Castor) Seed Oil, Helianthus Annus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Vitis Vinifera (Grape) Seed Oil, Rosa Canina (Rosehip) Seed Oil
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 chafed, chapped or cracked skin and lips. • Helps prevent and protect from the drying effects of wind and cold weather.
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.Evereden Multi-purpose Healing Balm Glycerin RICINUS COMMUNIS SEED HELIANTHUS ANNUUS SEED WAX GLYCERIN GLYCERIN VITIS VINIFERA SEED ROSA CANINA SEED HYDROGENATED CASTOR OIL
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.Secondary
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.WARNINGS • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 a doctor if: • conditions worsen • symptoms last more than 7 days or clear up and occur again within a few days • Do not use on: • Deep or puncture wounds • Animal bites • Serious burns
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