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Product NDC Code | 63710-001 | ||||
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Drug Name | Antibacterial 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 | 505G(a)(3) | ||||
Labeler Name | Laboratorios Zeyco, S.A. de C.V. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Composition: 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.Use instructions: Apply a small amount in the palm of your hand and distribute it across the entire surface of hands, rub them and allow the product to dry. Do not rinse hands.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.water, glycerin, crosslinked polyacrylate polymer and aminomethyl propanol.
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 instructions: Apply a small amount in the palm of your hand and distribute it across the entire surface of hands, rub them and allow the product to dry. Do not rinse hands.
Spl product data elements
Usually a list of ingredients in a drug product.Antibacterial Hand Sanitizer ALCOHOL WATER GLYCERIN AMINOMETHYLPROPANOL 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.THIS PRODUCT DOES NOT REPLACE WASHING WITH SOAP AND WATER.
Storage conditions: Store no more than 30°C.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not apply near eyes or irritated skin.
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 children. Flammable. Keep away of fire and heat.
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.If irritation or sensibility skin occur discontinue use of this product. In case of persisting symptoms, consult a physician. Avoid eye contact, if it occurs rinse out with water.
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.Precautions and safe handling: For external use only. Do not apply near eyes or irritated skin. If irritation or sensibility skin occur discontinue use of this product. In case of persisting symptoms, consult a physician. Avoid eye contact, if it occurs rinse out with water. Keep out of children. Flammable. Keep away of fire and heat.
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