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Byotrol hand sanitizer - Medication Information

Product NDC Code 63002-002
Drug Name

Byotrol hand sanitizer

Type Brand
Active Ingredients
Benzalkonium chloride 1.3 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1020365
Application Number part333A
Labeler Name Advanced Hygienics LLC
Packages
Package NDC Code Description
63002-002-12 1250 ml in 1 bottle (63002-002-12)
63002-002-50 500 ml in 1 bottle (63002-002-50)
63002-002-75 9463 ml in 1 bottle (63002-002-75)
63002-002-99 50 ml in 1 bottle (63002-002-99)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Benzalkonium Chloride 0.13%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Pump a small amount of foam onto hands. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients: Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Purpose

Information about the drug product’s indications for use.
Purpose Antimicrobial

Spl product data elements

Usually a list of ingredients in a drug product.
Byotrol Hand Sanitizer BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER CETRIMONIUM CHLORIDE LAURTRIMONIUM CHLORIDE GLYCERETH-17 COCOATE DIHYDROXYETHYL COCAMINE OXIDE POLIHEXANIDE CAPRYLYL GLUCOSIDE C12-15 PARETH-7 CITRIC ACID MONOHYDRATE DIMETHICONE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
byotrol ANTIBACTERIAL FOAMING HAND SANITIZER ALCOHOL FREE KILLS GERMS POWERFUL LONG LASTING GENTLE Net Contents: 16.9 FL OZ (500mL) container label

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-866-443-4509

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API