Drugplain

Hand Sanitizer Isopropyl Alcohol Antiseptic 75 .75 mL/mL

ISOPROPYL ALCOHOL · SOLUTION · Circadia by Dr Pugliese, Inc.

2 Recalls on Record
Plain English

Hand Sanitizer Isopropyl Alcohol Antiseptic 75 is a solution containing isopropyl alcohol at .75 mL/mL, taken topical. Manufactured by Circadia by Dr Pugliese, Inc..

Key Facts

Brand Name
Hand Sanitizer Isopropyl Alcohol Antiseptic 75
Generic Name
ISOPROPYL ALCOHOL
NDC Code (Product)
76458-400
Manufacturer
Circadia by Dr Pugliese, Inc.
Strength
.75 mL/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Marketing Start
04/06/2020

Recall History

2 Recalls on Record
Class I03/03/2022

Tennessee Technical Coatings, Corp.

Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.

TerminatedVoluntary: Firm initiated
Class II03/03/2022

Tennessee Technical Coatings, Corp.

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.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

glossodynia1,632 reports
pemphigus1,613 reports
hand deformity1,604 reports
joint swelling1,590 reports
infusion related reaction1,588 reports
helicobacter infection1,582 reports
impaired healing1,581 reports
irritable bowel syndrome1,574 reports
systemic lupus erythematosus1,569 reports
pericarditis1,561 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 Hand Sanitizer Isopropyl Alcohol Antiseptic 75 used for?

Hand Sanitizer Isopropyl Alcohol Antiseptic 75 contains ISOPROPYL ALCOHOL. It is a solution taken topical. Consult your doctor for specific uses.

Is Hand Sanitizer Isopropyl Alcohol Antiseptic 75 a controlled substance?

Hand Sanitizer Isopropyl Alcohol Antiseptic 75 is not classified as a controlled substance by the DEA.

What is the generic name for Hand Sanitizer Isopropyl Alcohol Antiseptic 75?

The generic name for Hand Sanitizer Isopropyl Alcohol Antiseptic 75 is ISOPROPYL ALCOHOL. There are 12 other brand versions of ISOPROPYL ALCOHOL.

What is the NDC code for Hand Sanitizer Isopropyl Alcohol Antiseptic 75 .75 mL/mL?

The NDC (National Drug Code) for Hand Sanitizer Isopropyl Alcohol Antiseptic 75 .75 mL/mL is 76458-400, listed by Circadia by Dr Pugliese, Inc..

Product NDC

76458-400

Package NDC

76458-400-08

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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)