Drugplain

Instant Hand Sanitizer .7 g/mL

alcohol · GEL · Safetec of America, Inc.

10 Recalls on RecordCurrently in Shortage
Plain English

Instant Hand Sanitizer is a gel containing alcohol at .7 g/mL, taken topical. Manufactured by Safetec of America, Inc..

Key Facts

Brand Name
Instant Hand Sanitizer
Generic Name
alcohol
NDC Code (Product)
61010-4111
Manufacturer
Safetec of America, Inc.
Strength
.7 g/mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
12/16/2010

Recall History

10 Recalls on Record
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 II01/28/2022

AMS Packaging Inc

Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

OngoingVoluntary: Firm initiated
Class II12/28/2012

Hillyard GMP

Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.

TerminatedVoluntary: Firm initiated
Class II07/11/2020

4e Brands North America, Llc

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class II06/01/2020

WORLD EVENT PROMOTIONS, LLC

Subpotent Drug: Product was found to be subpotent. Product also has high pH levels

TerminatedVoluntary: Firm initiated
Class II07/11/2020

4e Brands North America, Llc

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated
Class I07/20/2020

Liq-E S.A. De C.V.

Chemical Contamination: Products contain methanol and were below the label claim for ethanol content

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 II10/20/2023

Omega & Delta Co., Inc.

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

OngoingVoluntary: Firm initiated
Class I07/20/2020

Liq-E S.A. De C.V.

Chemical Contamination: Products contain methanol and were below the label claim for ethanol content

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

completed suicide8,204 reports
toxicity to various agents7,671 reports
drug abuse6,895 reports
death2,720 reports
overdose2,311 reports
cardio-respiratory arrest2,144 reports
intentional overdose1,937 reports
cardiac arrest1,577 reports
suicide attempt1,534 reports
respiratory arrest1,265 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for handwashing to decrease bacteria on skin recommended for repeated use

Dosage & Administration

Directions wet hands thoroughly with product allow to dry without wiping children under 6 should be supervised while using this product

Warnings

Warnings For external use only Flammable, keep away from fire or flame Do not use in the eyes. If this happens, rinse thoroughly with water Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours Keep out of reach of children If ingested get medical help or contact a Poison Control Center right away

Frequently Asked Questions

What is Instant Hand Sanitizer used for?

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

Is Instant Hand Sanitizer a controlled substance?

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

What is the generic name for Instant Hand Sanitizer?

The generic name for Instant Hand Sanitizer is alcohol. There are 12 other brand versions of alcohol.

What is the NDC code for Instant Hand Sanitizer .7 g/mL?

The NDC (National Drug Code) for Instant Hand Sanitizer .7 g/mL is 61010-4111, listed by Safetec of America, Inc..