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| Product NDC Code | 68016-370 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hand sanitizer |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 581662 | ||||||
| Application Number | part333A | ||||||
| Labeler Name | Pharmacy Value Alliance 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 Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 PV Independently Tested Satisfaction Guaranteed If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. DSP-TN-21091 DSP-MO-20087 DSP-MO-28 SDS-MO-20068
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethyl alcohol 70%
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 thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, carbomer or acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4
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 to decrease bacteria on the skin that could cause disease 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.Hand Sanitizer Alcohol ALCOHOL ALCOHOL water GLYCERYL CAPRYLATE/CAPRATE GLYCERIN ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL ACETATE CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) SULISOBENZONE
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 COMPARE TO PURELL ® ADVANCED HAND SANITIZER Premier Value Advanced Hand Sanitizer Kills more than 99.99% of germs* PV Independently Tested Satisfaction Guaranteed 8 FL OZ (236 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.Disclaimer *This product is not manufactured or distriubted by GOJO Industries, inc. distributer of Purell Advanced Hand Sanitizer. **Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds.
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 1-888-593-0593
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 skin irritation or redness develops 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 105⁰ 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 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