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| Product NDC Code | 57362-467 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Zylastxp antiseptic foaming |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SOAP | ||||||
| RxCUI drug identifier | 1243889 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | Innovative Biodefense | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Benzethonium Chloride - 0.20%
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 Wet hands and forearms. Apply one pump to hands and forearms thoroughly for 15 seconds or more. Rinse and repeat. For children under 6, use only with adult supervision.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alcohol Denatured, Aloe Barbadenis Lead Extract, Butylene Glycol, Cetrimonium Chloride, Citric Acid, Cocamidopropyl Betaiine, Farnesol, Fragrance, Glycerin, Lauramine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Polyaminopropyl Biguanide, Polyquaternium-10, PPG-12 Hydroxyethyl Cocamide, Water, Zinc Gluconate
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 Handwash to decrease bacteria on the skin. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.ZylastXP Antiseptic Foaming Benzethonium Chloride FARNESOL GLYCERIN METHYLCHLOROISOTHIAZOLINONE POLIHEXANIDE BENZETHONIUM CHLORIDE BENZETHONIUM WATER LAURAMINE OXIDE COCAMIDOPROPYL BETAINE CETRIMONIUM CHLORIDE BUTYLENE GLYCOL CITRIC ACID MONOHYDRATE ZINC GLUCONATE PPG-2 HYDROXYETHYL COCAMIDE
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 NDC 57362-467-01 Zylast Extended Protection Broad Spectrum Antimicrobial Antiseptic Foaming Soap 8.25 oz 8.25 oz
Package/Label Principal Display Panel NDC 57362-467-02 Zylast Extended Protection Broad Spectrum Antimicrobial Antiseptic Foaming Soap 1000mL (33.8oz) 1000mL
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Uses section Warnings section Inactive Ingredients section Directions section
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 Inforamtion Store at 20-25°C (68-77°F)
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 right away.
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 Irritation or redness develops. Condition persists for more than 72 hours.
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 use in or near eyes. In case of contact, rinse eyes throroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
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