Drugplain

Alcohol Antiseptic 70% Topical Solution 70 L/100L

ALCOHOL · GEL · Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc

5 Recalls on RecordCurrently in Shortage
Plain English

Alcohol Antiseptic 70% Topical Solution is a gel containing alcohol at 70 L/100L, taken topical. Manufactured by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

Key Facts

Brand Name
Alcohol Antiseptic 70% Topical Solution
Generic Name
ALCOHOL
NDC Code (Product)
68400-489
Manufacturer
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Strength
70 L/100L
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
06/01/2020

Recall History

5 Recalls on Record
Class II08/18/2020

GRUPO YACANA MEXICO SAS DE CV

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class I03/10/2021

PNHC, LLC.

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

TerminatedVoluntary: Firm initiated
Class II08/18/2020

GRUPO YACANA MEXICO SAS DE CV

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class I06/29/2020

Transliquid Technologies, LLC

Chemical Contamination: Presence of Undeclared Methanol

TerminatedVoluntary: Firm initiated
Class II03/10/2022

Rock Town Distillery, Inc.

CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

toxicity to various agents5,890 reports
completed suicide5,392 reports
drug abuse5,225 reports
overdose1,867 reports
death1,579 reports
intentional overdose1,523 reports
cardio-respiratory arrest1,339 reports
suicide attempt1,322 reports
somnolence899 reports
drug dependence897 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use(s) Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage & Administration

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Warnings

Warnings For external use only. Flammable. Keep away from heat or flame Do not use in children less than 2 months of age on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Alcohol Antiseptic 70% Topical Solution used for?

Alcohol Antiseptic 70% Topical Solution contains ALCOHOL. It is a gel taken topical. Consult your doctor for specific uses.

Is Alcohol Antiseptic 70% Topical Solution a controlled substance?

Alcohol Antiseptic 70% Topical Solution is not classified as a controlled substance by the DEA.

What is the generic name for Alcohol Antiseptic 70% Topical Solution?

The generic name for Alcohol Antiseptic 70% Topical Solution is ALCOHOL. There are 12 other brand versions of ALCOHOL.

What is the NDC code for Alcohol Antiseptic 70% Topical Solution 70 L/100L?

The NDC (National Drug Code) for Alcohol Antiseptic 70% Topical Solution 70 L/100L is 68400-489, listed by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.