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Plus brasept - Medication Information

Product NDC Code 83318-265
Drug Name

Plus brasept

Type Brand
Active Ingredients
Benzalkonium chloride 25 mg/ml
Route TOPICAL
Dosage Form SOAP
RxCUI drug identifier 1046529
Application Number part333E
Labeler Name NEWDROP NORTH AMERICA LLC
Packages
Package NDC Code Description
83318-265-41 3785 ml in 1 bottle, plastic (83318-265-41)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Drug Facts Box OTC-Active Ingredient Section Benzalkonium Chloride 2.5%

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.
Drug Facts Box OTC-Dosage & Administration Section wet hands and forearms apply 5 milliliters (teaspoonful) or palmful to hands and forearms scrub thoroughly for 1 minute and rinse

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Drug Facts Box OTC-Inactive Ingredient Section water, glycerin, isopropyl alcohol, disodium cocoamphodiproprionate, hydroxyethylcellulose, lauramine oxide, PEG-75 lanolin, citric acid, FD and C red no.4

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.
Drug Facts Box OTC-Indications & Usage Section for hand-washing to decrease bacteria on the skin

Purpose

Information about the drug product’s indications for use.
Drug Facts Box OTC-Purpose Section Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
PLUS BRASEPT BENZALKONIUM CHLORIDE WATER ISOPROPYL ALCOHOL HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) DISODIUM COCOAMPHODIPROPIONATE LAURAMINE OXIDE PEG-75 LANOLIN GLYCERIN CITRIC ACID MONOHYDRATE FD&C RED NO. 4 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.
PLUS BRASEPT 6265 PLUS BRASEPT 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.
Drug Facts Box OTC-Keep Out of Reach of Children Section if swallowed, get medical help or contact a Poison Control Center right away

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.
Drug Facts Box OTC-Stop Use Section irritation and redness develop

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.
Drug Facts Box OTC-When Using Section do not get into eyes if contact occurs, rinse eyes thoroughly 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.
Drug Facts Box OTC-Warnings Section For external use only

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