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| Product NDC Code | 57362-466 | ||||||||
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| Drug Name | Zylast antiseptic s |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 1491797 | ||||||||
| 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.Ethyl Alcohol - 76%
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 thoroughly with product and allow to dry without wiping. For children under 6, use only with adult supervision. Not recommended for use on infants.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Polyaminopropyl Biguanide, Panthenol, Farnesol, PEG-12, Dimethicone, Benzethonium Chloride
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 To decrease bacteria on skin. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Zylast Antiseptic S Ethyl Alcohol WATER ALCOHOL 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.NDC 57702-466-16 Zylast Antiseptic S 1000mL Broad Spectrum Antimicrobial NDC 57362-466-10 Zylast Antiseptic S 10mL vial 1000mL 10mL
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.Inidication of Use Warrnings When using this product Stop use and ask a doctor Keep out of reach of children Directions Package Label
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.Discontinue use if irritation and redness develops. Consult a doctor if condition persists for more than 72 hours.
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.If swallowed, get medical help or contact a Poison Control Center right away.
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.Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
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.Warning Section For external use only Flammable. Keep away from fire or flames.
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