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| Product NDC Code | 0519-6257 | ||||
|---|---|---|---|---|---|
| Drug Name | Septihol hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, FOAM | ||||
| RxCUI drug identifier | 1020364 | ||||
| Application Number | M003 | ||||
| Labeler Name | STERIS Corporation | ||||
| 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 ingredient Ethyl Alcohol 62% v/v
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 Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing until hands feel dry. Do not rinse or wipe off sanitizer.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Hydrofluorocarbon 152a, Isobutane, Emulsifying Wax, Cetyl lactate, Steareth-2, Sodium Benzoate, Sodium Sesquicarbonate
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 help decrease bacteria/germs on the skin that could cause disease. For use when soap and water are not available. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.Purposes Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Septihol Hand Sanitizer Alcohol Alcohol Alcohol water 1,1-Difluoroethane Isobutane Cetyl lactate Steareth-2 Sodium Benzoate SODIUM SESQUICARBONATE
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 - 255 g Bottle Label STERIS ® SEPTIHOL™ HAND SANITIZER Reorder Number: 625736 Contents: 9 oz (255g) NDC# 0519-6257-36 Antiseptic No-Rinse 62% Ethyl Alcohol by Volume Manufactured for: STERIS Corporation 7501 Page Avenue ■ St. Louis, MO 63133 ■ USA 800-548-4873 ■ www.steris.com PRINCIPAL DISPLAY PANEL - 255 g Bottle 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.Drug Facts
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 immediately.
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 physician if irritation occurs for more than 3 days, contact a physician.
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.When using this product Avoid contact with eyes. If splashed in eyes, rinse immediately and thoroughly with water. Do not use on open wounds, Discontinue use if irritation/redness occurs.
Storage and handling
Information about safe storage and handling of the drug product.Other Information For best foam density store and use at a temperature of 55 - 85˚F (13 - 29˚C)
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 . Flammable, keep away from fire or flame. Do not puncture or incinerate. Do not store above 120ºF (49ºC). When using this product Avoid contact with eyes. If splashed in eyes, rinse immediately and thoroughly with water. Do not use on open wounds, Discontinue use if irritation/redness occurs. Stop use and ask a physician if irritation occurs for more than 3 days, contact a physician. Keep out of reach of children. In case of ingestion, 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