Drugplain

Antibacterial 665 mL/L

alcohol · LIQUID · Henry Schein Inc.

10 Recalls on RecordCurrently in Shortage
Plain English

Antibacterial is a liquid containing alcohol at 665 mL/L, taken topical. Manufactured by Henry Schein Inc..

Key Facts

Brand Name
Antibacterial
Generic Name
alcohol
NDC Code (Product)
0404-0122
Manufacturer
Henry Schein Inc.
Strength
665 mL/L
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
11/11/2019

Recall History

10 Recalls on Record
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class II11/06/2024

Midlab Incorporated

cGMP Deviations: Out of specification results for micro in hand soap products.

OngoingVoluntary: Firm initiated
Class II06/12/2020

Beaming White Llc

Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.

TerminatedVoluntary: Firm initiated
Class III04/01/2019

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

TerminatedVoluntary: Firm initiated
Class II04/22/2019

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

TerminatedVoluntary: Firm initiated
Class II08/23/2017

Inopak Ltd

GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump

TerminatedVoluntary: Firm initiated
Class II09/03/2020

AJR TRADING LLC

CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

toxicity to various agents6,220 reports
completed suicide5,490 reports
drug abuse5,345 reports
overdose2,020 reports
death1,743 reports
intentional overdose1,560 reports
cardio-respiratory arrest1,369 reports
suicide attempt1,356 reports
drug ineffective1,293 reports
nausea1,114 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use For handwashing to decrease bacteria on the skin

Dosage & Administration

Directions wet hands apply palmful to hands scrub thoroughly rinse thoroughly

Warnings

Warnings For external use only: hands only

Frequently Asked Questions

What is Antibacterial used for?

Antibacterial contains alcohol. It is a liquid taken topical. Consult your doctor for specific uses.

Is Antibacterial a controlled substance?

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

What is the generic name for Antibacterial?

The generic name for Antibacterial is alcohol. There are 12 other brand versions of alcohol.

What is the NDC code for Antibacterial 665 mL/L?

The NDC (National Drug Code) for Antibacterial 665 mL/L is 0404-0122, listed by Henry Schein Inc..

Product NDC

0404-0122

Package NDC

0404-0122-02

Other Alcohol Brands

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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)