Antiseptic 500 mg/g
alcohol, lidocaine hydrochloride · LIQUID · Safetec of America, Inc.
Antiseptic is a liquid containing alcohol, lidocaine hydrochloride at 500 mg/g, taken topical. Manufactured by Safetec of America, Inc..
Key Facts
- Brand Name
- Antiseptic
- Generic Name
- alcohol, lidocaine hydrochloride
- NDC Code (Product)
61010-5200- Manufacturer
- Safetec of America, Inc.
- Strength
- 500 mg/g
- Dosage Form
- LIQUID
- Route
- TOPICAL
- Marketing Status
- Application #
- M003
- Marketing Start
- 09/30/2011
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?
Antiseptic contains alcohol, lidocaine hydrochloride. It is a liquid taken topical. Consult your doctor for specific uses.
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 alcohol, lidocaine hydrochloride. There are 1 other brand versions of alcohol, lidocaine hydrochloride.
What is the NDC code for Antiseptic 500 mg/g?
The NDC (National Drug Code) for Antiseptic 500 mg/g is 61010-5200, listed by Safetec of America, Inc..