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99 plus hand sanitizer - Medication Information

Product NDC Code 63533-457
Drug Name

99 plus hand sanitizer

Type Brand
Active Ingredients
Benzalkonium chloride 1.3 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1049254
Application Number part333E
Labeler Name Momar Incorporated
Packages
Package NDC Code Description
63533-457-10 1000 ml in 1 cartridge (63533-457-10)
63533-457-12 1000 ml in 1 bag (63533-457-12)
63533-457-14 3785 ml in 1 bottle, plastic (63533-457-14)
63533-457-18 50 ml in 1 bottle, plastic (63533-457-18)
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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 USP 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.
Drug Facts Box-OTC Dosage & Administration Section press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand rub hands together until dry wash hands with soap and water at earliest opportunity

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Drug Facts Box-OTC Inactive Ingredient Section water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate, methylchloroisothiazolinone, methylisothiazolinone, fragrance

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, only when water is not available

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.
99 Plus Hand Sanitizer BENZEALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER GLYCERIN DIMETHICONE DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE

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.
99 Plus Instant Hand Sanitizer 99 Plus Instant Hand Sanitizer product 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