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Product NDC Code | 69343-221 | ||||||||||||
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Drug Name | Elyptol antimicrobial rub |
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Type | Brand | ||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||
Dosage Form | SOLUTION | ||||||||||||
RxCUI drug identifier | 582753 | ||||||||||||
Application Number | part333A | ||||||||||||
Labeler Name | Elyptol Inc. | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients: Ethyl Alcohol 70% v/v
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 • HAND SANITISER/SKIN ANTISEPTIC: Apply Elyptol evenly and rub for 30 seconds. • SURGICAL HAND DISINFECTION: Apply Elyptol from forearms to fingertips. Rub evenly for 3 minutes, including between fingers and over nails. • PRE-OPERATIVE SKIN PREPARATION AND SKIN ANTISEPSIS: Apply Elyptol and rub evenly over desired area for 30 seconds.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Eucalyptus oil, Water, Glycerol, Cellulose, Piroctone Olamine.
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 To decrease bacteria on skin. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.Purpose Skin antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Elyptol Antimicrobial Rub Ethanol ALCOHOL ALCOHOL EUCALYPTUS OIL WATER GLYCERIN PIROCTONE OLAMINE
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.Packaging image description
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.INT PAT APP NO: PCT/2012/000841
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 reach of children Supervise children under 6 years. Not recommended for infants.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store below 30°C Keep out of direct sunlight.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? (866)701-8344
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 Flammable. Keep away from sources of fire or flame. If swallowed seek medical advice or contact a Poison Control Center, immediately. When using this product Do not ingest or inhale. Keep away from eyes. Use undiluted. Stop using and ask a doctor If redness or irritation develops. In case of eye contact, rinse eyes with water. If issues persist, seek medical attention.
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