Drugplain

Hand Sanitizer Gel .62 mL/mL

Hand Sanitizer Gel · GEL · LS Promotions Inc.

10 Recalls on Record
Plain English

Hand Sanitizer Gel is a gel containing hand sanitizer gel at .62 mL/mL, taken topical. Manufactured by LS Promotions Inc..

Key Facts

Brand Name
Hand Sanitizer Gel
Generic Name
Hand Sanitizer Gel
NDC Code (Product)
72449-103
Manufacturer
LS Promotions Inc.
Strength
.62 mL/mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
03/23/2020

Recall History

10 Recalls on Record
Class I05/12/2021

Global Sanitizers LLC

Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

OngoingVoluntary: Firm initiated
Class II05/12/2021

Global Sanitizers LLC

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

OngoingVoluntary: Firm initiated
Class II05/12/2021

Global Sanitizers LLC

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

OngoingVoluntary: Firm initiated
Class II08/25/2020

Asiaticon, SA de CV

Lack of CGMPs:

TerminatedVoluntary: Firm initiated
Class I03/23/2024

Aruba Aloe Balm N.V.

Chemical Contamination: Product manufactured with ethanol API that contains methanol

OngoingVoluntary: Firm initiated
Class II09/18/2024

EnviroServe Chemicals Inc.

CGMP deviations

OngoingVoluntary: Firm initiated
Class II09/11/2020

Genesis Partnership Company SA

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

OngoingVoluntary: Firm initiated
Class II02/19/2024

Seatex LLC

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

TerminatedVoluntary: Firm initiated
Class II05/12/2021

Global Sanitizers LLC

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

OngoingVoluntary: Firm initiated
Class II07/14/2020

Soluciones Cosmeticas, SA de CV

cGMP Deviations

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

completed suicide8,186 reports
toxicity to various agents7,639 reports
drug abuse6,850 reports
death2,713 reports
overdose2,282 reports
cardio-respiratory arrest2,145 reports
intentional overdose1,918 reports
cardiac arrest1,568 reports
suicide attempt1,515 reports
respiratory arrest1,264 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For hand Sanitizing

Dosage & Administration

Directions Wet hands throughly with product and allow to dry without wiping. For children under 6 age use only under adult supervision. Not recommended for infants.

Warnings

Warnings For external use only- hands. Flammable. Keep away from heat and flame.

Frequently Asked Questions

What is Hand Sanitizer Gel used for?

Hand Sanitizer Gel contains Hand Sanitizer Gel. It is a gel taken topical. Consult your doctor for specific uses.

Is Hand Sanitizer Gel a controlled substance?

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

What is the generic name for Hand Sanitizer Gel?

The generic name for Hand Sanitizer Gel is Hand Sanitizer Gel. There are 1 other brand versions of Hand Sanitizer Gel.

What is the NDC code for Hand Sanitizer Gel .62 mL/mL?

The NDC (National Drug Code) for Hand Sanitizer Gel .62 mL/mL is 72449-103, listed by LS Promotions Inc..

Product NDC

72449-103

Package NDC

72449-103-01

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

Data from openFDA · Public domain (CC0 1.0)