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Product NDC Code | 70299-001 | ||||||||
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Drug Name | Vytis shield aloe vera foam hand sanitizer |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | SPRAY | ||||||||
RxCUI drug identifier | 1020365 | ||||||||
Application Number | 505G(a)(3) | ||||||||
Labeler Name | Vytis Shield, Llc | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzalkonium chloride 0.13% Purpose Antiseptic Hand Sanitizer
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 a small amount into palms of hands and spread on both hands. Rub into skin until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients 1-Octadecanaminium NN dimethyl (3-trimethoxysilyl) propyl chloride, Aloe Barbadenis leaf extract, C12-C15 Pareth 12, Caprylyl Glucoside, Citric Acid Monohydrate, Citronellol, FD&C Blue 1, Glycerin, Polyaminopropyl biguanide, Sodium benzoate, 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 decrease bacteria on the skin. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.Vytis Shield Aloe Vera Foam Hand Sanitizer BENZALKONIUM CHLORIDE ALOE VERA LEAF CAPRYLYL GLUCOSIDE CITRIC ACID MONOHYDRATE .BETA.-CITRONELLOL, (R)- FD&C BLUE NO. 1 GLYCERIN POLYAMINOPROPYL BIGUANIDE SODIUM BENZOATE WATER 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 Labeling: Box
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.Drug Facts
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.Do not use in ears or mouth.
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. Children should be supervised when using this product. Do not freeze.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments Call:1-888-489-2719 Mon. - Fri. 9:00 AM to 5:00 PM (EST)
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 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 avoid contact with the 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 For external use only. Do not use in ears or mouth. When using this product avoid contact with the eyes. In case of contact flush eyes with water. Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours. Keep out of reach of children. Children should be supervised when using this product. Do not freeze.
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