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Product NDC Code | 63647-001 | ||||||
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Drug Name | Aloesept hs |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LIQUID | ||||||
RxCUI drug identifier | 582753 | ||||||
Application Number | part333E | ||||||
Labeler Name | Walter G. Legge Company, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient 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 If hands are visibly soiled, wash with soap and water and dry hands. Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, chlorhexidine gluconate, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, water.
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 decrease bacteria on the skin after changing diapers, assisting ill persons, or before contact with a person under medical care or treatment. Recommended for repeated use.
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.Aloesept HS Ethanol BENZALKONIUM CHLORIDE CHLORHEXIDINE GLUCONATE ISOPROPYL ALCOHOL PEG-10 DIMETHICONE (600 CST) POLYETHYLENE OXIDE 600000 PHENOXYETHANOL POLYQUATERNIUM-10 (1000 MPA.S AT 2%) WATER ALCOHOL ALCOHOL
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.ALOESEPT HS WATERLESS HAND SANITIZER Compliant with CDC Hand Hygiene Guidelines. Kills more than 99.99% of germs in 15 seconds. Does not contain DEA/MEA, triclosan, parabens, formaldehyde, dyes or fragrances. CONTAINS MOISTURIZING AGENTS 1000 ml 63647-001 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
Sold By: Walter G. Legge Company Inc. 444 Central Avenue, Peekskill, N.Y. 10566 1-800-345-3443 MADE IN THE USA
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.
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.Discontinue use if irritation occurs.
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.Keep out of eyes, ears, or mouth.
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 eyes, ears, or mouth. Discontinue use if irritation occurs. Keep out of reach of children. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.
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