Drugplain

Antibacterial Hand Sanitizer 620 mg/mL

ALCOHOL · SPRAY · TEKWELD SOLUTIONS, INC.

4 Recalls on RecordCurrently in Shortage
Plain English

Antibacterial Hand Sanitizer is a spray containing alcohol at 620 mg/mL, taken topical. Manufactured by TEKWELD SOLUTIONS, INC..

Key Facts

Brand Name
Antibacterial Hand Sanitizer
Generic Name
ALCOHOL
NDC Code (Product)
71160-189
Manufacturer
TEKWELD SOLUTIONS, INC.
Strength
620 mg/mL
Dosage Form
SPRAY
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
01/09/2017

Recall History

4 Recalls on Record
Class II12/15/2022

Frenda Corporation

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class II07/30/2020

Albek De Mexico S.A. De C.V.

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

OngoingVoluntary: Firm initiated
Class II07/30/2020

Albek De Mexico S.A. De C.V.

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

OngoingVoluntary: Firm initiated
Class II08/25/2020

Asiaticon, SA de CV

Lack of CGMPs:

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

toxicity to various agents5,927 reports
completed suicide5,410 reports
drug abuse5,270 reports
overdose1,897 reports
death1,589 reports
intentional overdose1,542 reports
suicide attempt1,341 reports
cardio-respiratory arrest1,339 reports
somnolence905 reports
drug dependence904 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Uses

Dosage & Administration

Dosage & Purpose Dosage and Purpose

Warnings

Warnings Warnings

Frequently Asked Questions

What is Antibacterial Hand Sanitizer used for?

Antibacterial Hand Sanitizer contains ALCOHOL. It is a spray taken topical. Consult your doctor for specific uses.

Is Antibacterial Hand Sanitizer a controlled substance?

Antibacterial Hand Sanitizer is not classified as a controlled substance by the DEA.

What is the generic name for Antibacterial Hand Sanitizer?

The generic name for Antibacterial Hand Sanitizer is ALCOHOL. There are 10 other brand versions of ALCOHOL.

What is the NDC code for Antibacterial Hand Sanitizer 620 mg/mL?

The NDC (National Drug Code) for Antibacterial Hand Sanitizer 620 mg/mL is 71160-189, listed by TEKWELD SOLUTIONS, INC..

Product NDC

71160-189

Package NDC

71160-189-05

Other Alcohol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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