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Product NDC Code | 55118-531 | ||||||||||
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Drug Name | Kleenex reveal moisturizing foam hand sanitizer |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | SOLUTION | ||||||||||
RxCUI drug identifier | 616805 | ||||||||||
Application Number | part333E | ||||||||||
Labeler Name | Kimberly-Clark | ||||||||||
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 Use enough foam to cover your hands. Supervise children when they use this product. For occasional and personal domestic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry. Use as part of your daily cleansing routine.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Extract, Betaine, Camellia Sensis Leaf Extract, Citric Acid, Cucumis Sativus Fruit Extract (Cucumber), Glycerin, Isopropanol, Meadowfoam Amidopropyl Betaine, Panthenol, PEG-10 Dimethicone, Water/Eau/Aqua
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 personal hand hygiene to help prevent the spread of bacteria. Kills harmful bacteria or germs.
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.Kleenex Reveal Moisturizing Foam Hand Sanitizer alcohol Alcohol Alcohol ALOE VERA LEAF Betaine GREEN TEA LEAF CITRIC ACID MONOHYDRATE CUCUMBER ISOPROPYL ALCOHOL Glycerin Meadowfoamamidopropyl Betaine Panthenol PEG-10 DIMETHICONE (600 CST) Water
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 - 532 mL Bottle Label Kleenex ® BRAND MARQUE REVEAL™ MOISTURIZING FOAM HAND SANITIZER ULTRA For Personal / Domestic Use Only 18 fl oz (532 mL) PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label
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 in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199. Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5
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 centre immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-346-4652
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 or persists
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 avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Report serious side effects from this product to 1-877-561-6587. Do not store above 110 °F (40 °C).
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 Flammability warning Keep away from open flame and sources of heat. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation or redness develops or persists Keep out of reach of children. If swallowed, get medical help or contact a poison control centre immediately.
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