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| Product NDC Code | 69674-100 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Hand sanitizer |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 616763 | ||||||||
| Application Number | part333E | ||||||||
| Labeler Name | Saraya Healthcare | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethanol 62%
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 Receive a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands, especially fingernails and cuticles Rub hands together until dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, DEA-C8-18 perfluoroalkylethyl phosphate, glycereth-2 cocoate, denatonium benzoate, tert-butyl 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 Sanitizes hands to help reduce bacteria that potentially can cause diseases Helps to prevent cross-contamination Helps to prevent drying of the skin Recommended for repeated use
Purpose
Information about the drug product’s indications for use.Purpose Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.Hand Sanitizer Ethanol DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE ALCOHOL ALCOHOL TERT-BUTYL ALCOHOL WATER GLYCERETH-2 COCOATE DENATONIUM BENZOATE
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.SARAYA Healthcare USA - Kills 99.999% of 26 tested pathogens in 15 seconds - Formulated with emollients to help keep hands soft - 62% Ethanol formula Hand Sanitizer Foam Net Contents: 1250mL (42 fl oz) Saraya Alc Hand Sanitizer Foam
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
Distributed by: Saraya Healthcare USA P.O. Box 1360 Penn Valley, CA 95946 866.822.1801 sarayahealthcareusa.com
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 In case of accidental ingestion, seek medical attention or contact a poison control center immediately
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Contact Saraya Healthcare USA Mon - Fri 9am - 4pm PST at 866.822.1801
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 Do not use in or near eyes Use in a well-ventilated area Discontinue use if irritation and redness develop
Storage and handling
Information about safe storage and handling of the drug product.Other information Store in a cool, dry place below 104°F
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
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