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Product NDC Code | 61139-701 | ||||
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Drug Name | Hand sanitizer fragrance free |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOLUTION | ||||
RxCUI drug identifier | 616805 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Office Max | ||||
Packages |
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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 Wet hands thoroughly with product and allow to dry without wiping.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Isopropyl Alcohol, PEG-12 Dimethicone, Glycerin, Caprylic/Capric Triglyceride, Isopropyl Myristate
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 Fragrance Free Ethyl Alcohol WATER ISOPROPYL ALCOHOL PEG-12 DIMETHICONE GLYCERIN GLYCERYL CAPRYLATE/CAPRATE ISOPROPYL MYRISTATE 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 MANUAL DISPENSER REFILL FOAM HAND SANITIZER FRAGRANCE FREE 33.9 fl oz (1000 mL) image description
principal display panel AUTOMATED DISPENSER REFILL FOAM HAND SANITIZER FRAGRANCE FREE 33.9 FL OZ (1000 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.Additional rear label text for manual dispensers HighMark Manual Dispenser Foam Hand Sanitzer Refill Distributed by: Office Depot, LLC 6600 N. Military Trail, Boca Raton, FL 33496 USA Highmark is a trademark or registered trademark of OMX, Inc. @2020 Office Depot, LLC. All Rights Reserved. Made in USA with foreign and domestic materials Manufactured for Georgia-Pacific Consumer Products LP, Atlanta, GA 30303 Questions? Call 1-877-674-0688 Alcohol permit SDS-MO-15036 DSP-MO-28 DSP-MO-34 33.9 FL OZ (1000 mL)
Additional rear label text for automatic dispensers HighMark Automatic Dispenser Foam Hand Sanitzer Refill Distributed by: Office Depot, LLC 6600 N. Military Trail, Boca Raton, FL 33496 USA Highmark is a trademark or registered trademark of OMX, Inc. @2020 Office Depot, LLC. All Rights Reserved. Made in USA with foreign and domestic materials Manufactured for Georgia-Pacific Consumer Products LP, Atlanta, GA 30303 Questions? Call 1-877-674-0688 Alcohol permit SDS-MO-15036 DSP-MO-28 DSP-MO-34 33.9 FL OZ (1000 mL)
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, seek immediate medical attention or call a poison control center.
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 or redness develops. If condition persists for more than 72 hours consult a doctor.
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
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 FLAMMABLE, keep away from fire and flame 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