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Product NDC Code | 79432-001 | ||||||
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Drug Name | Mediclean sanitizing wipes |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CLOTH | ||||||
RxCUI drug identifier | 1038558 | ||||||
Application Number | 505G(a)(3) | ||||||
Labeler Name | Industrias Maqun, S.A. de C.V. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Activate ingredient Benzalkonium Chloride 0.13% Purpose Antimicrobial
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 thoroughly with product and allow to dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Aqua, Laurylamine Dipropylenediamine, Propylene Glycol USP, Phenoxyethanol, Fragrance, PEG 40 Hydrogenated Castor Oil, Glycerin, Sodium Cocoamphoacetate, Isopropyl Alcohol, Citric Acid, Tetrasodium EDTA, Laureth-7 Citrate.
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 Hand Sanitizer to help reduce 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.Mediclean Sanitizing Wipes BENZALKONIUM CHLORIDE WATER N-(3-AMINOPROPYL)-N-DODECYL-1,3-PROPANEDIAMINE PROPYLENE GLYCOL PHENOXYETHANOL POLYOXYL 40 HYDROGENATED CASTOR OIL GLYCERIN SODIUM COCOAMPHOACETATE ISOPROPYL ALCOHOL CITRIC ACID MONOHYDRATE EDETATE SODIUM 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.Package Labeling:84 Label
Package Labeling:120 Label2
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.DRUGS 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. Children under 6 years of age should be supervised whenusing . MEDICLEAN
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions and comments: www.Industriasmaquinsa.com.mx Call: 1 800 XXX XXX XXX / [email protected]
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 using and ask a doctor if: Irritation or rash appears and lasts.
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. Do not use in or near the eyes, in case of contact, rinse eyes throughly 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. Do not use in or near the eyes, in case of contact, rinse eyes throughly with water. Stop using and ask a doctor if: Irritation or rash appears and lasts. Keep out of reach of children: If swallowed get medical help or contact a poison control center right away. Children under 6 years of age should be supervised whenusing . MEDICLEAN
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