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Product NDC Code | 80228-2001 | ||||
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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 | M003 | ||||
Labeler Name | Universal Synergetics, Inc | ||||
Packages |
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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 Put enough in palm to cover hands - Rub hands briskly until dry. - 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 Water(Aqua) Alicyle Acrylate, Crosspolymer, Aminomethyl Propanol, Caprylyl Glycol, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Fragrance, Tocopherol Acetate
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 Hand sanitizer to help reduce bacteria on skin.
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.Hand Sanitizer Alcohol WATER CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) AMINOMETHYLPROPANOL CAPRYLYL GLYCOL GLYCERIN ISOPROPYL ALCOHOL 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 Principal Display Panel - 1.2 mL Pouch Label
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 call a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information: Store below 110° F (43°C) May discolor certain fabrics and surfaces
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions: 833-523-1109
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 rash develops and lasts
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 -For external use only - Avoid eye contact. If in the eyes flush with water. Stop use and ask a doctor if irritation or rash develops and lasts - Keep out of reach of children - If swallowed get medical help or call a Poison Control Center right away.
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