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| Product NDC Code | 63146-311 | ||||
|---|---|---|---|---|---|
| Drug Name | Retail hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1039483 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Kay Chemical Company | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethanol 60% by volume
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 liberal amount into hand Spread by rubbing hands together Rub to dryness with attention to are around nails and between fingers
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water (aqua), isopropyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, myristyl alcohol
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 For handwashing to decrease bacteria on the skin
Purpose
Information about the drug product’s indications for use.Purpose Antispetic handwash
Spl product data elements
Usually a list of ingredients in a drug product.Retail Hand Sanitizer Alcohol ALCOHOL ALCOHOL WATER ISOPROPYL ALCOHOL TROLAMINE CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) PROPYLENE GLYCOL MYRISTYL 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 and representative label NDC 63146-311-09 RETAIL Hand Sanitizer Sanitizante de manos KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY MANTENGASE FUERA DEL ALCANCE DE LOS NIÑOS • SOLO PARA USO INSTITUCIONAL Ethanol 60% by volume 60% de etanol por volume Net contents: 40.6 US fl oz (1200 ml) FRSUSA 777648/8000/0920 Meets the requirements for Hand Antiseptics as specified in section 2-301.16 of the 2017 Model Food Code. Cumple con los requisitos estipulados de antisépticos para manos tal como se especifican en la sección 2-301.16 del Código Modelo para Alimentos (2017 Model Food Code). SDS-NC-872, SDS-NJ-20007 Distributed by / Distribuido por: Kay Chemical Company 8300 Capital Drive · Greensboro, NC 27409-9790 USA Customer Service: (800) 529-5458 ©2020 Kay Chemical Company All rights reserved | Todas los derechos reservados Made in USA | Hecho en Estados Unidos This product may be patented | Este producto puede ser patentado: www.ecolab.com/patents representative label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if Eye or skin irritation or redenss occurs for more than 72 hours
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 eyes On deep cuts or puncture 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? Call 1-800-529-5458
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 If in eyes, rinse promptly and thoroughly with water Discontinue use if irritation and rendess develop
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.Other information For additional information, see Safety Data Sheet (SDS) For emergency medical information in USA, call (877) 231-2615 or call collect 0 (952) 853-1713
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 FLAMMABLE, keep away from fire or flame, heat, sparks and sources of static discharge Do not use In eyes On deep cuts or puncture wounds When using this product If in eyes, rinse promptly and thoroughly with water Discontinue use if irritation and rendess develop Stop use and ask a doctor if Eye or skin irritation or redenss occurs for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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