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| Product NDC Code | 49351-304 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tork hand washing antibacterial foam |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SOAP | ||||||
| RxCUI drug identifier | 1046593 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | Essity Professional Hygiene North America LLC | ||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reaction 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 Components Patents: www.essity.com/patents
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 wet hands, dispense enough to cover both hands, rub for 30 seconds then rinse with clean water for 30 seconds
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water//equ/aqua, caprylyl/capryl glucoside, laurtrimonium chloride, cocamidopropylamine oxide, lauryl glucoside, citric acid
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 handwashing 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 Washing Antibacterial Foam Benzalkonium Chloride WATER CAPRYLYL GLUCOSIDE LAURTRIMONIUM CHLORIDE COCAMIDOPROPYLAMINE OXIDE LAURYL GLUCOSIDE CITRIC ACID MONOHYDRATE 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 microorganisms tested under ASTM E2783-11 in 30 seconds TORK NDC 49351-304-01 Tork Antibacterial Hand Washing Foam Soap Benzalkonium Chloride 0.13% NSF Nonfood Compounds Program Listed E2 167747 40 18 15 S4 1L (33.8 FL OZ) Peel Here image description
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 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 and redness develope condition persists for more then 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