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Product NDC Code | 49351-303 | ||||||
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Drug Name | Tork hand sanitizing alcohol-free foam |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 1020365 | ||||||
Application Number | 505G(a)(3) | ||||||
Labeler Name | Essity Professional Hygiene North America 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%
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 Dispense enough to spread on both hands to wrists, then rub into skin for 30 seconds. Allow to dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, lactic acid, phenoxyethanol, sodium hydroxide, propylene glycol, cocamidopropyl betaine, sodium cocoamphoacetate
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
Spl product data elements
Usually a list of ingredients in a drug product.Tork Hand Sanitizing Alcohol-Free Foam Benzalkonium Chloride WATER LACTIC ACID PHENOXYETHANOL SODIUM HYDROXIDE PROPYLENE GLYCOL COCAMIDOPROPYL BETAINE SODIUM COCOAMPHOACETATE 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.Principal panel display Kills 99.9% of Common Germs* *based on majority of microorgnisms tested under ASTM E2783-11 in 30 seconds NDC 49351-303-02 TORK Tork Hand Sanitizing Alcohol-Free Foam Benzalkonium Chloride, 0.13% 1.5 FL OZ (44 mL) image description
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.essity Manufactured for Essity Professional Hygiene North America LLC 2929 Arch Street Philadelphia, Pennsylvania 19104 www.essity.com, www.torkusa.com made in USA from Domestic & Imported Components Patents/Brevets/Patentes: www.essisty.com/patents NOT FOR SALE Can be ordered as: 401813 for S4, 1000ml
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 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 medial help or contact a Posion Control Center right away.
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? 1-866-722-8675
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 irritation and redness develop condition persists 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 keep out of eyes, ears, and mouth In case of contact with eyes, rinse eyes thoroughly with water do not ingest
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
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