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Product NDC Code | 80937-222 | ||||
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Drug Name | Dena-vie first aid antiseptic |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
RxCUI drug identifier | 1014638 | ||||
Application Number | part333A | ||||
Labeler Name | Dena Brands Usa Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Isopropyl alcohol USP (70 % conc.)
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: clean affected area; • spray small amount of this product on the area 1-3 times daily; • if bandaged, let dry first; • may be covered with a sterile bandage.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient: Deionized Water
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 First aid to help prevent the risk of infection in minor cuts, scrapes, and burns.
Purpose
Information about the drug product’s indications for use.Purpose First aid antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Dena-Vie First Aid Antiseptic Isopropyl alcohol WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL
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.Packaging IMAGE
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
For Rubbing & Massaging WARNING FLAMMABLE Keep away from heat, spark, electrical, fire or flame. USE ONLY IN A WELL-VENTILATED AREA, FUMES MAY BE HARMFUL CAUTION: DO NOT POINT AT SELF OR OTHERS; PRODUCT WILL SQUIRT WHEN SQUEEZED Dena Vie Division of Dena Brands USA Ltd P.O. Box 66445, Chicago, Illinois 60666 USA www.denabrandsusa.com Made in the USA
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. In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Storage and handling
Information about safe storage and handling of the drug product.Other information: Store at room temperature; • does not contain, nor is intended as a substitute for grain or ethyl alcohol.
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. If taken internally, serious gastric disturbances will result. Flammable, keep away from fire or flame. Use only in a well-ventilated area; fumes may be toxic. Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns. When using this product: Do not get into eyes ; • Do not spray over large areas of the body; • Do not use longer than one week unless directed by a doctor. Stop use and ask a doctor if condition persists or gets worse. Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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