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Product NDC Code | 54622-313 | ||||
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Drug Name | Gp pbu antimicrobial foam |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOLUTION | ||||
RxCUI drug identifier | 1046593 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Georgia Pacific Consumer Products | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 Wet hands, apply soap, rub hands togetehr vigorously for at least 20 seconds. Rinse and dry hands thoroughly.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Lauramine Oxide, Lauryl Betaine, Glycerin, Laurtrimonium Chloride, Sodium PCA, Tocopheryl Acetate, Oleth-10, Tetrasodium EDTA, Citric Acid, Red 40, Yellow 6, Fragrance
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.Use Handwash to help reduce bacteria that potentially can cause disease.
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.GP PBU Antimicrobial Foam Benzalkonium Chloride SODIUM PYRROLIDONE CARBOXYLATE LAURAMINE OXIDE LAURYL BETAINE GLYCERIN LAURTRIMONIUM CHLORIDE EDETATE SODIUM FD&C YELLOW NO. 6 OLETH-10 FD&C RED NO. 40 ANHYDROUS CITRIC ACID WATER BENZALKONIUM CHLORIDE BENZALKONIUM .ALPHA.-TOCOPHEROL ACETATE
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.1 2
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, seek immediate medical attention or call a poison control center.
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 if irritation or redness developes. If condition persists for more than 72 hours consult a doctor.
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 the eyes. In case of eye contact, flush 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 When using this product Avoid contact with the eyes. In case of eye contact, flush with water. Stop use if irritation or redness developes. If condition persists for more than 72 hours consult a doctor. Keep out of reach of children If swallowed, seek immediate medical attention or call a poison control center.
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