Antiseptic 100 mg/mL
benzalkonium chloride, benzocaine · SPRAY · JHK Inc
This topical spray combines benzalkonium chloride (an antiseptic) and benzocaine (a local anesthetic) to help clean and numb minor cuts, scrapes, and skin irritations. It is available over-the-counter for direct application to affected skin areas.
Key Facts
- Brand Name
- Antiseptic
- Generic Name
- benzalkonium chloride, benzocaine
- NDC Code (Product)
73598-0681- Manufacturer
- JHK Inc
- Strength
- 100 mg/mL
- Dosage Form
- SPRAY
- Route
- TOPICAL
- Marketing Status
- Application #
- M004
- Drug Class
- Standardized Chemical Allergen [EPC]
- Marketing Start
- 02/14/2020
Recall History
Ecometics, Inc.
CGMP DEVIATIONS
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Nanomaterials Discovery Corporation
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
ACME UNITED CORPORATION
CGMP Deviations
ACME UNITED CORPORATION
CGMP Deviations
GRUPO YACANA MEXICO SAS DE CV
cGMP Deviations
Humco Holding Group, Inc
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Tennessee Technical Coatings, Corp.
Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
WALKER EMULSIONS INC
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
PNHC, LLC.
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Drug Facts Box OTC-Indications & Usage Section for hand-washing to decrease bacteria on the skin
Dosage & Administration
Drug Facts Box OTC-Dosage & Administration Section wet hands and forearms apply 5 milliliters (teaspoonful) or palmful to hands and forearms scrub thoroughly for 1 minute and rinse
Warnings
Drug Facts Box OTC-Warnings Section For external use only
Frequently Asked Questions
What is Antiseptic used for?
This topical spray combines benzalkonium chloride (an antiseptic) and benzocaine (a local anesthetic) to help clean and numb minor cuts, scrapes, and skin irritations. It is available over-the-counter for direct application to affected skin areas.
Is Antiseptic a controlled substance?
Antiseptic is not classified as a controlled substance by the DEA.
What is the generic name for Antiseptic?
The generic name for Antiseptic is benzalkonium chloride, benzocaine. There are 5 other brand versions of benzalkonium chloride, benzocaine.
What is the NDC code for Antiseptic 100 mg/mL?
The NDC (National Drug Code) for Antiseptic 100 mg/mL is 73598-0681, listed by JHK Inc.