Drugplain

Antibacterial Hand 6.1 g/L

chloroxylenol · SOAP · Henry Schein, Inc.

10 Recalls on Record
Plain English

Antibacterial Hand is a soap containing chloroxylenol at 6.1 g/L, taken topical. Manufactured by Henry Schein, Inc..

Key Facts

Brand Name
Antibacterial Hand
Generic Name
chloroxylenol
NDC Code (Product)
0404-4438
Manufacturer
Henry Schein, Inc.
Strength
6.1 g/L
Dosage Form
SOAP
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
01/30/2013

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 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 II08/06/2013

Showline Automotive Products, Inc. dba US Soaps Mfg. Company

Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.

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

Side Effects Reported to FDA

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

toxicity to various agents5,928 reports
completed suicide5,410 reports
drug abuse5,270 reports
overdose1,903 reports
death1,621 reports
intentional overdose1,542 reports
suicide attempt1,342 reports
cardio-respiratory arrest1,340 reports
somnolence905 reports
drug dependence904 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 and rinse with water.

Warnings

Warnings For external use only KEEP OUT OF REACH OF CHILDREN. May cause moderate eye irritation. Avoid contact with eyes and skin. If in eyes, flush eyes gently with water for 15 minutes. If swallowed, drink water to dilute. If irritation persists, contact a Physician or Poison Control Center.

Frequently Asked Questions

What is Antibacterial Hand used for?

Antibacterial Hand contains chloroxylenol. It is a soap taken topical. Consult your doctor for specific uses.

Is Antibacterial Hand a controlled substance?

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

What is the generic name for Antibacterial Hand?

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

What is the NDC code for Antibacterial Hand 6.1 g/L?

The NDC (National Drug Code) for Antibacterial Hand 6.1 g/L is 0404-4438, listed by Henry Schein, Inc..