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Product NDC Code | 70108-087 | ||||
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Drug Name | Smart care crayola hand sanitizer |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
RxCUI drug identifier | 1041849 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Ashtel Studios, Inc. | ||||
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 • Adults and children 6 years and older Spray onto hands and rub together until dry. Recommended for repeat use. • Children under 6 years of age should be supervised when using this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Gel, Aminomethyl Propanol, Denatonium Benzoate, Fragrance, Glycerin, Tocopheryl Acetate, Water
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 Decreases bacteria on 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.Smart Care Crayola HAND SANITIZER Ethyl Alcohol ALCOHOL ALCOHOL ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) ALOE VERA LEAF AMINOMETHYLPROPANOL DENATONIUM BENZOATE GLYCERIN .ALPHA.-TOCOPHEROL ACETATE 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.Packaging CrayolaHandSanitizerSpray-087
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
*Effective at killing 99.9% Escherichia coli, Staphylococcus aureus. OFFICIAL LICENSED PRODUCT QUALITY GUARANTEE Ashtel Studios Inc. guarantees the quality of this Crayola product. If this product does not perform properly, please contact us at 1-877-274-8358, Monday-Friday 8AM - 5PM. PST ABOUT US Crayola A Hallmark Company ©2024 CRAYOLA, EASTON, PA 18044-0431. Crayola TM and Serpentine Design TM are trademarks of Crayola used under license. DESIGNED IN U.S.A. MANUFACTURED IN CHINA Smart Care ® WWW.SMARTCAREUS.COM 1-909-434-0911 INTERNATIONAL PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761
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 immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll free 1-877-274-8358
Storage and handling
Information about safe storage and handling of the drug product.Other Information • Store between 15-30C (59-86F) • Avoid freezing and excessive heat above 40C (104F)
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. Keep away from fire or flame. Do not use • If you are allergic to any of the ingredients When using this product • Do not get into eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor • If irritation or rash develops and continues for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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