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| Product NDC Code | 66949-105 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Zep fs antimicrobial hand cleaner |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LIQUID | ||||||||||
| RxCUI drug identifier | 1046593 | ||||||||||
| Application Number | 505G(a)(3) | ||||||||||
| Labeler Name | Zep 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 0.13%
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 with water. Place hands under dispenser and apply liquid soap. Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles. Rinse hands thoroughly and dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Didecyldimonium Chloride, Cocamidopropyl Hydroxysultaine, Lauramine Oxide, PEG-6 Cocamide, Hydroxyethylcellulose, Methylchloroisothiazolinone and Methylisothiazolinone, Citric Acid
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 Hand washing to decrease bacteria on skin. For use in food processing facilities.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic Hand Wash
Spl product data elements
Usually a list of ingredients in a drug product.Zep FS Antimicrobial Hand Cleaner Benzalkonium Chloride WATER PEG-6 COCAMIDE METHYLISOTHIAZOLINONE BENZALKONIUM CHLORIDE BENZALKONIUM DIDECYLDIMONIUM CHLORIDE LAURAMINE OXIDE COCAMIDOPROPYL HYDROXYSULTAINE METHYLCHLOROISOTHIAZOLINONE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ANHYDROUS CITRIC ACID
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.105_3153
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 and pets Keep out of reach of children and pets. Children must be supervised in use of this product.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at 20 to 25°C (68 to 77°F). Do not freeze. Dispose in accordance with all applicable federal, state and local regulations.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-877-I-BUY-ZEP (1-877-428-9937)
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 doctor Stop use and ask a doctor if skin irritation or redness persists for more than 72 hours.
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 Do not swallow. If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.
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 the eyes; if in eyes, rinse promptly and thoroughly with water.
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