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| Product NDC Code | 63900-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Foaming alcohol hand sanitizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 616763 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Simoniz USA, Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethyl Alcohol 62% (v/v) Purpose Antiseptic
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 If hands are visibily soiled, wash with soap and water and dry hands. Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycereth-2-cocoate, DEA-C8-18 Perfluroalkylethyl Phosphate, 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.Use For handwashing to decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment. 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.Foaming Alcohol Hand Sanitizer ALCOHOL GLYCERETH-2 COCOATE DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE WATER 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.Package Labeling: 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
Other Information Store between 59-86°F (15-30°C) Avoid freezing and excessive heat above 104°F (40°C)
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 FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME
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.Discontinue use if irritation occurs
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. Keep out of eyes, ears or mouth. Discontinue use if irritation occurs Keep out of reach of children 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