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Product NDC Code | 72197-009 | ||||
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Drug Name | Sanitaxe antibacterial |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
Application Number | part333E | ||||
Labeler Name | American Consumer Products Corp | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Active Ingredient Benzalkonium Chloride .26%
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 Directions ● pump as needed on your palms and thoroughly spread on both hands ● rub into skin until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Inactive ingredients: Water (Aqua), Cocamidopropyl Betane, PEG-6000 Disterate, Sodium Cocoamphoacetate, Fragrance, Citric Acid, Methylisothiazolinone, Iodopropynyl Butylcarbamate
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 Uses ● Helps reduce bacteria on the skin that could cause disease. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.Purpose Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Sanitaxe Antibacterial Benzalkonium Chloride COCAMIDOPROPYL BETAINE ANHYDROUS CITRIC ACID WATER BENZALKONIUM CHLORIDE BENZALKONIUM SODIUM COCOAMPHOACETATE METHYLISOTHIAZOLINONE IODOPROPYNYL BUTYLCARBAMATE PEG-250 DISTEARATE
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.Sanitaxe Hand Soap Sanitaxe Hand Soap
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information Other information ● store at room 20° C (68° to 77° F) ● may discolor fabrics.
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. Do not use on children less than 2 months of age. Supervise use in children under 6 years of age to prevent accidental swallowing. 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.Stop use and ask a doctor Stop use and ask a doctor if redness or irritation develops and 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 When using this product, avoid contact with eyes. In case of 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 Warnings – For external use only. Do not ingest or swallow. Flammable. Keep away from fire or flame. Do not apply around eyes. Do not use in ears & mouth.
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