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| Product NDC Code | 47593-404 | ||||
|---|---|---|---|---|---|
| Drug Name | Digisan e |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1038799, 1038834 |
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| Application Number | 505G(a)(3) | ||||
| Labeler Name | Ecolab Inc. | ||||
| 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 Benzalkonium chloride, 0.1%
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 remove soil dispense palmful spread to cover hands, rub in well air dry, do not rinse or towel dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: water (aqua), isopropyl alcohol, propylene glycol, FD&C red 40, F&DC blue 1
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.DigiSan E Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER ISOPROPYL ALCOHOL PROPYLENE GLYCOL FD&C RED NO. 40 FD&C BLUE NO. 1
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/Representative Label ECOLAB 6123674 DigiSan™ E Foam Hand Sanitizer 750 mL (25 US FL OZ) Active Ingredient: Benzalkonium chloride 0.1% 706304/5405/1020 This product may be patented www.ecolab.com/patents Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326) 5105 Tomken Road · Mississauga ON L4W 2X5 Canada © 2020 Ecolab USA Inc · All rights reserved Made in U.S.A. www.ecolab.com 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 1-800-35-CLEAN (352-5326)
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 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 Safety Data Sheet (SDS) For emergency medical information in USA and Canada, call 1-800-328-0026 For emergency medical information worldwide, call 1-651-222-5352 (in USA)
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, heat sparks and sources of static discharge Do not use In eyes When using this product 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