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B.clean hand sanitizer (foam) - Medication Information

Product NDC Code 73978-002
Drug Name

B.clean hand sanitizer (foam)

Type Brand
Active Ingredients
Benzalkonium chloride .25 g/100ml
Route TOPICAL
Dosage Form GEL
Application Number part333A
Labeler Name Marque of Brands Americas, LLC
Packages
Package NDC Code Description
73978-002-01 29 ml in 1 bottle, plastic (73978-002-01)
73978-002-02 177 ml in 1 bottle, pump (73978-002-02)
73978-002-03 946 ml in 1 bottle, pump (73978-002-03)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Benzalkonium Chloride

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.
Place enough product on hands to cover all surfaces. Rub hands together until dry Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol,Tocopheryl Acetate, Squalane, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Disodium Laureth Sulfosuccinate, Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Sodium Methyl Cocoyl Taurate, Phenoxyethanol, Citric Acid, Fragrence

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.
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.
b.clean hand sanitizer (foam) ALCOHOL DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE DISODIUM LAURETH SULFOSUCCINATE SODIUM COCOYL ISETHIONATE COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE PHENOXYETHANOL CITRIC ACID MONOHYDRATE WATER BENZALKONIUM CHLORIDE BENZALKONIUM ALPHA-TOCOPHEROL ACETATE SQUALANE PROPYLENE GLYCOL GLYCERIN ALOE VERA LEAF

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.
label

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
in children less than 2 months of age on open skin wounds

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

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.
and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.
Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse throughly 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.
Warning Flammable, keep away from flame. 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