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| Product NDC Code | 63146-105 | ||||
|---|---|---|---|---|---|
| Drug Name | Fortress |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 436367 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Kay Chemical Co. | ||||
| 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 Chloroxylenol 0.5%
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 Dispense a palmful of product to hands Scrub hands and forearms for 20 seconds Rinse thoroughly and dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, citric acid, coco-glucoside, glyceryl oleate, fragrance, methychloroisothiazolinone, CI 19140 (FD&C Yellow No. 5), methylisothiazolinone, CI 14700 (FDC Red No. 4)
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 For handwashing to decrease bacteria on the skin.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic Handwash
Spl product data elements
Usually a list of ingredients in a drug product.Fortress Chloroxylenol CHLOROXYLENOL CHLOROXYLENOL WATER POTASSIUM COCOATE HEXYLENE GLYCOL SODIUM SULFATE EDETATE SODIUM SODIUM LAURYL SULFATE GLYCERIN ANHYDROUS CITRIC ACID COCO GLUCOSIDE GLYCERYL OLEATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 FD&C RED NO. 4
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 and representative label FORTRESS® Foaming Antibacterial Hand Soap KEEP OUT OF REACH OF CHILDREN/FOR INSTITUTIONAL USE ONLY FORTRESS® Foaming Antibacterial Hand Soap is a rich lather hand soap with a balanced blend of cleaning agents and skin protecting moisturizers. Instant foam lathers fast • Mild, pH-balanced formula Fresh, clean fragrance To obtain Spanish instructions, see outer carton. Para obtener las instrucciones en español, véase la caja exterior. NDC.: 63146-105-03 KAY CHEMICAL COMPANY 8300 Capital Drive Greensboro, NC 27409-3790, USA Customer Service: (800) 529-5458 706402-04 KUSA 706402/8004/0412 ©2012 Kay Chemical Company All Rights Reserved 25 US fl OZ (750 ml) representative 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.Stop use and ask a doctor if Skin irritation or redness occurs for more than 72 hours
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
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-529-5458
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 If in eyes, rinse promptly and thoroughly with water Discontinue use if irritation and redness develop
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.Other Information for additional information, see Material Safety Data Sheet (MSDS) for emergency medical information in USA, call (877) 231-2615 or call collect 0 (952) 853-1713
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 When using this product If in eyes, rinse promptly and thoroughly with water Discontinue use if irritation and redness develop Stop use and ask a doctor if Skin irritation or redness occurs for more than 72 hours Keep out of reach of children. 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