Benzalkonium chloride 1.3 mg/mL
Benzalkonium chloride · LIQUID · Nice-Pak Products, LLC
Benzalkonium chloride is a liquid containing benzalkonium chloride at 1.3 mg/mL, taken topical. Manufactured by Nice-Pak Products, LLC.
Key Facts
- Brand Name
- Benzalkonium chloride
- Generic Name
- Benzalkonium chloride
- NDC Code (Product)
11344-628- Manufacturer
- Nice-Pak Products, LLC
- Strength
- 1.3 mg/mL
- Dosage Form
- LIQUID
- Route
- TOPICAL
- Marketing Status
- Application #
- 505G(a)(3)
- Marketing Start
- 12/20/2016
Recall History
Sanit Technologies, LLC dba Durisan
Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
Diamond Wipes International, Inc.
CGMP Deviations: finished products were manufactured with poor quality water.
Martin Avenue Pharmacy, Inc.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
HLI dba Humphreyline Inc
Microbial Contamination of Non-Sterile Product
ACME UNITED CORPORATION
CGMP Deviations
AVKARE Inc.
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
ACME UNITED CORPORATION
CGMP Deviations
S.C. Johnson Professional
CGMP Deviations: Product was released to market prior to microbiological testing.
Humco Holding Group, Inc
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Kimberly-Clark Corporation
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses Hand Sanitizer to help reduce bacteria on the skin Recommended for repeated use
Dosage & Administration
Directions Take wipe and rub thoroughly over all surface of both hands. Wet hands thoroughly with wipes. Rub hand together briskly to dry without wiping. Dispose of wipe. Do not flush.
Warnings
Warnings For external use only.
Frequently Asked Questions
What is Benzalkonium chloride used for?
Benzalkonium chloride contains Benzalkonium chloride. It is a liquid taken topical. Consult your doctor for specific uses.
Is Benzalkonium chloride a controlled substance?
Benzalkonium chloride is not classified as a controlled substance by the DEA.
What is the generic name for Benzalkonium chloride?
The generic name for Benzalkonium chloride is Benzalkonium chloride. There are 12 other brand versions of Benzalkonium chloride.
What is the NDC code for Benzalkonium chloride 1.3 mg/mL?
The NDC (National Drug Code) for Benzalkonium chloride 1.3 mg/mL is 11344-628, listed by Nice-Pak Products, LLC.
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- Equate Antibacterial Fresh Hand Wipes.115 g/179903-110
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)