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Product NDC Code | 69221-501 | ||||||
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Drug Name | Zoono ultra hand sanitizer |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 582753 | ||||||
Application Number | 505G(a)(3) | ||||||
Labeler Name | Zoono Holdings USA, LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethyl Alchol 70% 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 Apply liberally to the hands and gently rub until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Alcohol, Benzalkonium chloride, Fragrance, Polysorbate, Silica Complex 3-(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, 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 For personal hand sanitizing and to reduce bacteria on the skin. 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.Zoono Ultra Hand Sanitizer Alcohol 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.Zoono Ultra Hand Sanitizer Zoono Ultra Hand Sanitizer
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 Cener right away.
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? Telephone: 1-844-966-6687 Monday through Friday 8:00am till 5:00pm EST
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 and redness develop.
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. In case of eye contact flush eyes 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.Warnings For external use only. Do not use in the eyes. When using this product avoid contact with eyes. In case of eye contact flush eyes with water. Stop use and ask a doctor if irritation and redness develop. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Cener 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