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Product NDC Code | 73857-003 | ||||
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Drug Name | Theorie antimicrobial hand wash |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOAP | ||||
RxCUI drug identifier | 1089990 | ||||
Application Number | part333E | ||||
Labeler Name | Dynastis, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.DRUG FACTS 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 For maximum efficiency, pump the product into wet hands, lather vigorously, sinse and dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Coco Glucoside, Glycerin, Polysorbate-20, PEG-150 Pentaerythrityl Tetrastearate, PEG-6 Caprylic/Capric Glycerides, Guar Hydroxypropyltrimonium Chloride, Polyquaternium-10, Sodium Hyaluronate, Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, 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.Stop use and ask a doctor if : irritation or rash occurs. These maybe signs of a serious condition.
Purpose
Information about the drug product’s indications for use.Uses For hand washing to decrease bacteria that can potentially cause disease.
Spl product data elements
Usually a list of ingredients in a drug product.Theorie Antimicrobial Hand WASH Benzalkonium Chloride WATER SODIUM C14-16 OLEFIN SULFONATE COCAMIDOPROPYL BETAINE COCO GLUCOSIDE GLYCERIN POLYSORBATE 20 PEG-150 PENTAERYTHRITYL TETRASTEARATE PEG-6 CAPRYLIC/CAPRIC GLYCERIDES GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) POLYQUATERNIUM-10 (30000 MPA.S AT 2%) HYALURONATE SODIUM .ALPHA.-TOCOPHEROL ACETATE ARGAN OIL SCLEROCARYA BIRREA SEED OIL PHENOXYETHANOL ETHYLHEXYLGLYCERIN CITRIC ACID MONOHYDRATE 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.400ml label
1.5L 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.Other Information Store at room temperature 68°F to 77°F (20° to 25°C) Do not expose to excessive heat. You may report a serious adverse reaction to: Hautehouse, LLC, 909 NW Terrace, Fort Lauderdale, FL 33311 USA
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use • in children less than 2 months of age • on open skin wounds
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.For Questions HAUTEHOUSE INC. 909 NW Terrace Fort Lauderdale, FL 33311 USA +1 (954) 376-8966 www.hautehouse.com
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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Children must be supervised when using this product.
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 . If swallowed, get medical help or contact a Poison Control Center immediately.
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