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Product NDC Code | 49351-301 | ||||||||||
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Drug Name | Tork hand sanitizing alcohol foam |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | LIQUID | ||||||||||
RxCUI drug identifier | 616805 | ||||||||||
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 Ethyl alcohol 70% v/v
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 and wrists, then rub into skin for at least 30 seconds. Allow to dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, PEG-8 Dimethicone, meadowfoamamidopropyl betaine, glyceryl caprylate/caprate, glycerin, tocopheryl acetate, isopropyl myristate
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 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 Foam Alcohol WATER PEG-8 DIMETHICONE MEADOWFOAMAMIDOPROPYL BETAINE GLYCERYL CAPRYLATE/CAPRATE GLYCERIN .ALPHA.-TOCOPHEROL ACETATE ISOPROPYL MYRISTATE ALCOHOL ALCOHOL
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 display panel Kills 99.99% of Many Common Germs* *based on ASTM E2315-16 in 60 seconds NDC 49351-301-01 TORK ® Tork Hand Sanitizing Alcohol Foam Ethyl alcohol, 70% v/v UL ECOLOGO Product certified for reduced environmental impact: View specific attributes evaluated: UL.comel UL 2783 NSF Nonfood compounds program Listed E3 registration #165960 USDA CERTIFIED BIOBASED PRODUCT Product 98% GREEN SEAL CERTIFIED greenseal.org 40 02 17 S4 1L (33.8 FL OZ) Peel Here 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.DSP-TN-21091 DSP-MO-20087 DSP-MO-28 SDS-MO-20068 TORK essity Manufactured for Essity Professional Hygiene North America LLC 2929 Arch Street Philadelphia, Pennsylvania 19104 www.essity.com, www.torkusa.com Made in USA of Domestic and Imported Compnents Patents: www.essity.com/patents
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 children If swallowed, get medical help or contact a Poison 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 or redness develop condition 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 keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin do not inhale or ingest
Storage and handling
Information about safe storage and handling of the drug product.Other information do not store above 105° F may discolor some fabrics harmful to wood finishes and plastics
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: hands only Flammable, keep away from fire or flame.
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