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| Product NDC Code | 83986-028 | ||||
|---|---|---|---|---|---|
| Drug Name | Hand sanitizing wipes |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CLOTH | ||||
| RxCUI drug identifier | 1489307 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | UpLift Brands 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 Vi-Jon, LLC St. Louis, MO 36114 Questions? 1-866-MY-GERMX
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 wipe hands thoroughly with product and allow to dry for children under 6, use only under adult supervison not recommended for infants
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, glycerin, glyceryl caprylate/caprate, Aloe barbadensis leaf juice, isopropyl myristate, tocopheryl acetate, fragrance
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.Use to decrease bacteria on the skin
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 Sanitizing Wipes Ethyl Alcohol WATER GLYCERIN GLYCERYL MONOCAPRYLOCAPRATE ALOE VERA LEAF ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL ACETATE 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 germ-X ® SINCE 1997 ADVANCED 70% ALCOHOL HAND SANITIZER WIPES Kills more than 99.99% of Germs* with added moisturizers FRESH SCENT 20 SOFT WIPES DO NOT FLUSH LIFE 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.Claims germ-x SINCE 1997 ADVANCED 70% ALCOHOL HAND SANITIZER WIPES
Claims Great for on the Go! OFFICE SCHOOL ON-THE-GO Germ-X Advanced Hand Sanitizing wipes contian moisturizers while killing 99.99% of many common germs in as little as 15 seconds. Convenient, easy to carry and can be used anywhere. To Open: Peel up film label slowly. To Dispense: Grab wipe and pull through opening. To Reseal: Run thumb firmly down over label to seal. To Dispose: Place in trash can after use. Do Nut Flush *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. In case of accidental ingestion, see professional assistance or contact a Poison Control Center immediately.
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 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 105º F may discolor some fabrics or surfaces 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