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Proclean foam nexa hand sanitizer - Medication Information

Product NDC Code 47593-657
Drug Name

Proclean foam nexa hand sanitizer

Type Brand
Active Ingredients
Benzalkonium chloride .1 mg/100ml
Route TOPICAL
Dosage Form SOLUTION
Application Number 505G(a)(3)
Labeler Name Ecolab Inc.
Packages
Package NDC Code Description
47593-657-41 750 ml in 1 bottle, plastic (47593-657-41)
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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.
Direction wash hands to 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, FD&C 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.
ProClean Foam Nexa Hand Sanitizer 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 and representative label ProSystem Proclean Foam Nexa Hand Sanitizer Active Ingredient: Benzalkonium chloride 0.1% 6102737 750 mL (25 US FL OZ) Manufactured by Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326) © 2024 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 our 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.
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 Safety Data Sheet (SDS) EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).

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 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 our 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