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Pre fense - Medication Information

Product NDC Code 48404-051
Drug Name

Pre fense

Type Brand
Active Ingredients
Benzalkonium chloride 120 mg/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1052949
Application Number 505G(a)(3)
Labeler Name Prefense LLC
Packages
Package NDC Code Description
48404-051-01 44.4 ml in 1 bottle (48404-051-01)
48404-051-02 237 ml in 1 bottle (48404-051-02)
48404-051-03 1000 ml in 1 pouch (48404-051-03)
48404-051-04 1893 ml in 1 jug (48404-051-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Drug Facts Active Ingredient Benzalkonium Chloride ............0.12%

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: Apply to dry hands, rub together, and let dry.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: 3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, East Indian Lemongrass Oil, Isotonic Sodium Chloride Solution, Orange Oil, Water

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: Hand sanitizer to help reduce germs that potentially cause disease.

Purpose

Information about the drug product’s indications for use.
Purpose Hand and Skin Sanitizer

Spl product data elements

Usually a list of ingredients in a drug product.
pre fense BENZALKONIUM CHLORIDE ISOTONIC SODIUM CHLORIDE SOLUTION DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE METHYL ALCOHOL ANHYDROUS CITRIC ACID WATER COCAMIDOPROPYL BETAINE EAST INDIAN LEMONGRASS OIL ORANGE OIL (3-CHLOROPROPYL)TRIMETHOXYSILANE BENZALKONIUM CHLORIDE BENZALKONIUM

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.
Package Label - 1 Liter Pouch pre•fense ™ Hand Sanitizer Original lemongrass scent protects kills up to 99.99% of germs on contact Moisturizes silica based, alcohol-free alcohol-free won't dry out skin www.prefense.com Made in USA DO NOT FREEZE 33.82 fl. oz./1 Liter Label

Recent major changes

A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.
Usage statement changed to standard monograph language of "Hand sanitizer to help reduce germs that potentially cause disease." Directions statement changed to "Apply to dry hands, rub t ogether, and let dry."

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 Keep out of reach of children.

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.
Warning: For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.

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