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| Product NDC Code | 69740-492 | ||||
|---|---|---|---|---|---|
| Drug Name | Dermal wound cleanser |
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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 | Smith & Nephew Medical Ltd. | ||||
| 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 apply a small amount of this product on the area 1 to 3 times daily rinse as per normal protocol cover wound with sterile dressing or bandage as needed if applying dressing or bandage, let dry first
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS benzyl alcohol, citric acid, disodium EDTA, glycerin, polyquaternium-10, polysorbate 20, sodium citrate, 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 reduce the risk of infection in minor cuts, scrapes and burns aids in the removal of foreign materials such as dirt and debris
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.Dermal Wound Cleanser BENZETHONIUM CHLORIDE BENZYL ALCOHOL EDETATE DISODIUM GLYCERIN POLYSORBATE 20 WATER SODIUM CITRATE ANHYDROUS CITRIC ACID BENZETHONIUM CHLORIDE BENZETHONIUM POLYQUATERNIUM-10 (125 MPA.S AT 2%) Dermal Wound Cleanser BENZETHONIUM CHLORIDE POLYQUATERNIUM-10 (125 MPA.S AT 2%) BENZYL ALCOHOL WATER EDETATE DISODIUM GLYCERIN POLYSORBATE 20 SODIUM CITRATE ANHYDROUS CITRIC ACID 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.PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - DERMAL WOUND CLEANSER BOTTLE, SPRAY (473 mL) Smith&Nephew REF 449000 NDC 69740-490-00 Dermal Wound Cleanser First Aid Antiseptic Helps reduce risk of infection in wounds and burns Gentle wound cleansing Safe and easy to use pH-buffered Non-irritating 16 fl. oz. (473 mL) Made in the USA for Smith & Nephew Medical Ltd. 101 Hessle Road Hull HU3 2BN England www.smith-nephew.com Package Display - Bottle, Spray (473mL)
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - DERMAL WOUND CLEANSER BOTTLE, SPRAY (236 mL) Smith&Nephew #59449200 NDC 69740-492-00 Dermal Wound Cleanser First Aid Antiseptic Helps reduce risk of infection in wounds and burns Gentle wound cleansing Safe and easy to use pH-buffered Non-irritating 8 fl. oz. (236 mL) Made in the USA for Smith & Nephew Medical Ltd. 101 Hessle Road Hull HU3 2BN England www.smith-nephew.com Package Display - Bottle, Spray (236mL)
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 contains antimicrobial ingredient
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 the eyes or apply over large areas of the body
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.QUESTION OR COMMENTS? 1 800 876-1261
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.In case of deep or puncture wounds, animal bites, or serious burns, contact a doctor Stop use and contact a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor
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.For external use only
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 the eyes or apply over large areas of the body In case of deep or puncture wounds, animal bites, or serious burns, contact a doctor Stop use and contact a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately For external use only Do not use in the eyes or apply over large areas of the body In case of deep or puncture wounds, animal bites, or serious burns, contact a doctor Stop use and contact a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor 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