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Product NDC Code | 67777-233 | ||||
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Drug Name | Dynarex hydrogel |
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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 | GEL | ||||
Application Number | M016 | ||||
Labeler Name | Dynarex Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Active Ingredient Purpose Glycerin 20.0% Skin Protectant
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.Dosage & Administration Dynarex Hydrogel Apply Wound Gel liberally to cover involved areas; apply as often as necessary. If gauze is used as a wound covering, moisten first.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Inactive ingredients: Allantoin, Aloe Vera Gel, Diazolidinyl Urea, Methyparaben, PEG-4 Olivate, PEG-60 Hydrogenated Castor Oil, Propylene Glycol, Propylparaben, Purified Water, Sodium Polyacrylate, Tetrasodium EDTA, Tocopherol Acetate.
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.Indications and Usage: Use: For dressing and management of stasis ulcers, pressure ulcers (stages I-IV) 1st and 2nd degree burns, cuts abrasions, skin irritations, post operative incisions, and skin conditions associated with peristomal care.
Purpose
Information about the drug product’s indications for use.Purpose For dressing and management of stasis ulcers, pressure ulcers (stages I-IV) 1st and 2nd degree burns, cuts abrasions, skin irritations, post operative incisions, and skin conditions associated with peristomal care.
Spl product data elements
Usually a list of ingredients in a drug product.Dynarex Hydrogel glycerin METHYLPARABEN PROPYLENE GLYCOL POLYOXYL 60 HYDROGENATED CASTOR OIL PROPYLPARABEN WATER EDETATE SODIUM ALPHA-TOCOPHEROL ACETATE GLYCERIN GLYCERIN ALLANTOIN ALOE VERA LEAF DIAZOLIDINYL UREA SODIUM POLYACRYLATE (8000 MW)
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.1280 IN MASTER
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 KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
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 If condition worsens or does not improve within 10-14 days, consult a physician. Keep this and all medications out of the reach of children. Follow directions for use.
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