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Product NDC Code | 59555-501 | ||||||||||||
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Drug Name | I.c. antibacterial hand cleaner with pumice |
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Type | Brand | ||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||
Dosage Form | SOAP | ||||||||||||
RxCUI drug identifier | 1046593 | ||||||||||||
Application Number | part333A | ||||||||||||
Labeler Name | R & R Lotion, Inc | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Benzalkonium Chloride 0.13%
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 into DRY hands. Lather vigorously for at least 15 seconds Rinse and dry throughly
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Cocamide MEA, Carbopol SF-2, Xanthan Gum, Sodium Laureth Sulfate, Cocamidopropyl Betaine, TEA Lauryl Sulfate, Triethanolamine 99, Geogard Ultra, Sodium Chloride, Citric Acid, Sodium Hydroxide, Pumice
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 hand washing to decrease bacteria on the skin
Purpose
Information about the drug product’s indications for use.Purpose Antibacterial
Spl product data elements
Usually a list of ingredients in a drug product.I.C. Antibacterial Hand Cleaner with Pumice Benzalkonium Chloride Benzalkonium Chloride BENZALKONIUM water Triethanolamine Lauryl Sulfate SODIUM LAURETH-3 SULFATE Cocamidopropyl Betaine COCO MONOETHANOLAMIDE SODIUM CHLORIDE GLUCONOLACTONE SODIUM BENZOATE CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE ACRYLATES CROSSPOLYMER-6 TROLAMINE Xanthan Gum
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.PRINCIPAL DISPLAY PANEL - 946 ml Bottle Label I.C. ® Antibacterial Hand Cleaner with Pumice R&R LOTION USA Kills Germs 32oz. (946ml) ℮ PRINCIPAL DISPLAY PANEL - 946 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. If swallowed, get medical help or contact a poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Samples & Comments? Call (480) 443-9255
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.
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 Avoid contact with eyes. In case of eye contact, flush with water. Stop use and ask a doctor if irritation or redness develops. Keep out of reach of children. 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