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Product NDC Code | 51628-0033 | ||||
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Drug Name | Xtra antibacterial hand juicy orange |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 413261 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | MY IMPORTS USA, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Chloroxylenol 0.30% Purpose Antibacterial hand soap
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 Apply palmful to wet hands. Scrub and rinse thoroughly.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Deionized Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Fragrance, Sodium Hydroxide, Lactic Acid, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C yellow no.5, FD&C red no.40
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 handwashing, to reduce bacteria on skin
Purpose
Information about the drug product’s indications for use.Purpose Antibacterial hand soap
Spl product data elements
Usually a list of ingredients in a drug product.Xtra Antibacterial Hand Juicy Orange CHLOROXYLENOL WATER SODIUM LAURETH-3 SULFATE SODIUM CHLORIDE COCAMIDOPROPYL BETAINE GLYCERIN SODIUM HYDROXIDE LACTIC ACID, UNSPECIFIED FORM MAGNESIUM NITRATE METHYLCHLOROISOTHIAZOLINONE MAGNESIUM CHLORIDE METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 FD&C RED NO. 40 CHLOROXYLENOL CHLOROXYLENOL
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: 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. Avoid contact with eyes. If eye contact occures flush thoroughly with water. Do not ingest. If ingested, drink plenty of water, contact a physician.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions/Comments? Call toll-free 1-877-879-6999 or email us at [email protected]
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. Keep out of reach of children. Avoid contact with eyes. If eye contact occures flush thoroughly with water. Do not ingest. If ingested, drink plenty of water, contact a physician.
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