Hand Sanitizer with Aloe 65 g/100g

65% Ethyl Alcohol · GEL · Owen Biosciences, Inc.

1 Recall on Record

Plain English

Hand Sanitizer with Aloe is a gel containing 65% ethyl alcohol at 65 g/100g, taken topical. Manufactured by Owen Biosciences, Inc..

Key Facts

Brand Name: Hand Sanitizer with Aloe
Generic Name: 65% Ethyl Alcohol
NDC Code (Product): 59958-500
Manufacturer: Owen Biosciences, Inc.
Strength: 65 g/100g
Dosage Form: GEL
Route: TOPICAL
Marketing Status
Application #: 505G(a)(3)
Marketing Start: 03/23/2020

Recall History

1 Recall on Record

Class II04/22/2019

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

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 agents7,666 reports

drug abuse6,895 reports

death2,717 reports

overdose2,308 reports

cardio-respiratory arrest2,145 reports

intentional overdose1,937 reports

cardiac arrest1,572 reports

suicide attempt1,534 reports

respiratory arrest1,263 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use To decrease bacteria on the skin that could cause disease. Recommended for repeaed use.

Dosage & Administration

Directions Wet hands thoroughly with product and allow to dry without wiping. For hildren under 6, use only under adult supervision. Not recommended for infants.

Warnings

Warnings For external use only: hands Flammable. Keep away from heat and flame. When using this product Keep out of eyes. In case of contact with eyes, fllush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and ask a doctor if skin irritation develops. Other Information Do not store above 105℉. May discolor some fabrics. Harmful to wood finisheds and plastics. 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 with Aloe used for?

Hand Sanitizer with Aloe contains 65% Ethyl Alcohol. It is a gel taken topical. Consult your doctor for specific uses.

Is Hand Sanitizer with Aloe a controlled substance?

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

What is the generic name for Hand Sanitizer with Aloe?

The generic name for Hand Sanitizer with Aloe is 65% Ethyl Alcohol. There are no other listed brand versions of 65% Ethyl Alcohol.

What is the NDC code for Hand Sanitizer with Aloe 65 g/100g?

The NDC (National Drug Code) for Hand Sanitizer with Aloe 65 g/100g is 59958-500, listed by Owen Biosciences, Inc..

Product NDC

59958-500

Package NDC

59958-500-07

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

Data from openFDA · Public domain (CC0 1.0)