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| Product NDC Code | 71489-008 | ||||||||||||||||||||||||||||||||||
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| Drug Name | Saniluxe hand sanitizer alcohol free |
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| Type | Brand | ||||||||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | CUTANEOUS | ||||||||||||||||||||||||||||||||||
| Dosage Form | GEL | ||||||||||||||||||||||||||||||||||
| RxCUI drug identifier | 1049228 | ||||||||||||||||||||||||||||||||||
| Application Number | 505G(a)(3) | ||||||||||||||||||||||||||||||||||
| Labeler Name | Celeste Industries Corporation | ||||||||||||||||||||||||||||||||||
| 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 Benzalkonium Chloride 0.1%
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 Pump a small amount of gel into palm of hand Rub hands together briskly until dry Rub thoroughly over all surfaces of both hands
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Triethylene Glycol, Glycereth-26, Cocamidopropyl PG-Dimonium Cloride Phosphate,Hydroxyethylcellulose, DMDM Hydantoin, Triethanolamine, Fragrance (Aroma), Iodopropynyl Butyl Carbamate, 1, 3-Butanediol
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.SaniLuxe Hand Sanitizer Alcohol Free BENZALKONIUM CHLORIDE WATER TRIETHYLENE GLYCOL GLYCERETH-26 COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) DMDM HYDANTOIN TROLAMINE IODOPROPYNYL BUTYLCARBAMATE BUTYLENE GLYCOL BENZALKONIUM CHLORIDE BENZALKONIUM
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.SaniLuxe™ HAND SANITIZER GEL Alcohol free 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. If swallowed, get medical help or contact a Poison Control Center right away.
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. Keep out of reach of children. 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 or redness develops, or if condition persists for more than 72 hours. If swallowed, get medical help or contact 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