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| Product NDC Code | 71489-007 | ||||||||||||||||||||||||||||||||||
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| Drug Name | Sani luxe hand sanitizer with alcohol |
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| Type | Brand | ||||||||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | CUTANEOUS | ||||||||||||||||||||||||||||||||||
| Dosage Form | GEL | ||||||||||||||||||||||||||||||||||
| RxCUI drug identifier | 1860080 | ||||||||||||||||||||||||||||||||||
| Application Number | 505G(a)(3) | ||||||||||||||||||||||||||||||||||
| Labeler Name | Celeste Industries Corporation | ||||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl Alcohol 62.5%
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 Children under 6 years of age should be supervised when using this product Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua, PEG-4 Diheptanoate, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Fragrance, Aminomethyl Propanol May contain hydroxypropylcellulose.
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 Recommended for repeated use For hand sanitizing to decrease bacteria on the 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.Sani Luxe Hand Sanitizer with Alcohol ALCOHOL WATER PEG-4 DIHEPTANOATE CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) AMINOMETHYLPROPANOL HYDROXYPROPYL CELLULOSE, UNSPECIFIED 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.Sani Luxe ® HAND SANITIZER GEL with Alcohol Requires no water or towels. Apply small amount to hands and rub until dry. Kills 99% of germs on contact Caution: Use on hands only. 284ml e PRINCIPAL DISPLAY PANEL - 284 ml Bottle 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
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.
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 redness develops, or if condition persists for more than 72 hours.
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. If swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store below 110°F (43°C) May discolor certain fabrics or surfaces.
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. Flammable. Keep away from open flame and sources of heat. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children.
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