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| Product NDC Code | 54622-572 | ||||
|---|---|---|---|---|---|
| Drug Name | Pacific blue ultra |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOAP | ||||
| RxCUI drug identifier | 1046593 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Georgia-Pacific Consumer Products LP | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Manual Dispensers Adverse Reactions and Additional Rear Text Pacific Blue Ultra ™ Antimicrobial Foam Soap Fragrance Free - SKU 43818 NSF Nonfood Compounds Program Listed E2 154304 Manufactured for Georgia-Pacific Consumer Products. Atlanta, GA 30303 Quesitons? Call 1-866-HELLOGP (435-5647) or visit us online at www.gppro.com (c) 2024 GP PRO. All rights reserved.
Automatic Dispensers Adverse Reactions and Additional Rear Text Pacific Blue Ultra ™ Automated Antimicrobial Foam Soap Fragrance Free - SKU 43822 NSF Nonfood Compounds Program Listed E2 154304 Manufactured for Georgia-Pacific Consumer Products. Atlanta, GA 30303 Quesitons? Call 1-866-HELLOGP (435-5647) or visit us online at www.gppro.com (c) 2024 GP PRO. All rights reserved.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium chloride 0.13% w/w
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 together vigorously for at least 20 seconds. Rinse and dry hands thoroughly with a disposable paper towel.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Lauramine Oxide, Lauryl Betaine, Laurtrimonium Chloride, Glycerin, Sodium PCA, Tocopheryl Acetate, Olrth-10, Tetrasodium EDTA, Citric Acid
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 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.Pacific Blue Ultra Benzalkonium Chloride .ALPHA.-TOCOPHEROL ACETATE OLETH-10 LAURAMINE OXIDE SODIUM PYRROLIDONE CARBOXYLATE WATER BENZALKONIUM CHLORIDE BENZALKONIUM EDETATE SODIUM LAURYL BETAINE LAURTRIMONIUM CHLORIDE CITRIC ACID MONOHYDRATE GLYCERIN
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 Antimicrobial Foam Soap 1200 mL (40.5 FL OZ) mm01
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 our 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 and ask a doctor if irritation or redness develops. 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 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
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