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| Product NDC Code | 71029-390 | ||||
|---|---|---|---|---|---|
| Drug Name | Sterile antibacterial wound wash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 582205 | ||||
| Application Number | M003 | ||||
| Labeler Name | Cosrich Group, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Benzethonium Chloride 0.13%
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 the affected area shake well remove seal and cap spray a small amount of this product on the area 1 to 3 times a day may be covered with a sterile bandage. If bandaged, let dry first
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Extract, benzalkonium chloride, Purified Water, Sodium Chloride U.S.P.
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 bacterial contamination 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.Sterile Antibacterial Wound Wash Benzethonium Chloride ALOE VERA LEAF WATER SODIUM CHLORIDE BENZALKONIUM CHLORIDE BENZETHONIUM CHLORIDE BENZETHONIUM
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.Principal Display Panel NDC 71029-390-04 PRO+ECT Antibacterial WOUND WASH FIRST AID CLEANSER Cleans wounds painlessly and effectively No burn or sting No alcohol No fragrance ECO-FRIENDLY No Fluorinated Hydrocarbon Propellants COMPRESSED AIR IS THE PROPELLANT SPRAYS UPSIDE DOWN OR AT ANY ANGLE NO PUMPING NEEDED 360 0 CONTINUOUS SPRAY 4 FL.OZ (120 mL) Label
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.Other information Do not puncture or incinerate can. Contents under pressure drop can store at temperatures above 120 o F. use if tamper evident seal is broken
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use in the event of deep puncture wounds, animal bites or severe burns
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use in eyes over large areas of the body longer than 1 week unless directed by a doctor
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 childrens 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? 1-800-831-7210
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 a doctor if condition persists or gets worse
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 Do not use in eyes over large areas of the body longer than 1 week unless directed by a doctor Ask a doctor before use in the event of deep puncture wounds, animal bites or severe burns Stop use and ask a doctor if condition persists or gets worse Keep out of reach of childrens 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