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Saniluxe hand sanitizer alcohol free - Medication Information

Product NDC Code 71489-008
Drug Name

Saniluxe hand sanitizer alcohol free

Type Brand
Active Ingredients
Benzalkonium chloride 1 mg/ml
Route CUTANEOUS
Dosage Form GEL
RxCUI drug identifier 1049228
Application Number 505G(a)(3)
Labeler Name Celeste Industries Corporation
Packages
Package NDC Code Description
71489-008-01 284 ml in 1 bottle, pump (71489-008-01)
71489-008-02 177 ml in 1 bottle (71489-008-02)
71489-008-03 59 ml in 1 bottle, pump (71489-008-03)
71489-008-04 237 ml in 1 bottle, pump (71489-008-04)
71489-008-05 355 ml in 1 bottle, pump (71489-008-05)
71489-008-06 3785 ml in 1 bottle (71489-008-06)
71489-008-07 59 ml in 1 bottle (71489-008-07)
71489-008-08 177 ml in 1 bottle, pump (71489-008-08)
71489-008-09 237 ml in 1 bottle (71489-008-09)
71489-008-10 284 ml in 1 bottle (71489-008-10)
71489-008-11 355 ml in 1 bottle (71489-008-11)
71489-008-12 3785 ml in 1 bottle, pump (71489-008-12)
71489-008-13 946 ml in 1 bottle (71489-008-13)
71489-008-14 946 ml in 1 bottle, pump (71489-008-14)
71489-008-15 530 ml in 1 bottle (71489-008-15)
71489-008-16 530 ml in 1 bottle, pump (71489-008-16)
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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