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| Product NDC Code | 65616-009 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sterillium comfort |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 1041851 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | BODE Chemie GmbH | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl Alcohol 85% 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 Wet hands thoroughly with product and allow to dry without wiping Supervise children in the use of this product
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Bisabolol, Cyclomethicone, Glycerin, Isohexadecane, Isopropyl Alcohol, Myristyl Alcohol, PVP, Tetrahydroxypropyl Ethylenediamine, 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. 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.Sterillium Comfort Alcohol CYCLOMETHICONE WATER LEVOMENOL GLYCERIN ISOHEXADECANE ISOPROPYL ALCOHOL POVIDONE K90 EDETOL CARBOMER INTERPOLYMER TYPE A (55000 CPS) MYRISTYL ALCOHOL 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.BODE Sterillium Comfort Gel HEALTHCARE PERSONNEL HAND RUB 85% v/v ethyl alcohol with moisturizers Kills > 99.999% of germs in 15 seconds without water. Boosts skin moisture level. Leaves hands feeling soft and healthy. Dermatologically tested. Read Drug Facts panel before use. Lot: Use by: Questions? Call 1-800-MEDLINE NDC 65616-009-06 1000 mL 33.8 fl.oz. (1QT 1.8 FL OZ) container label container label container label container label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Directions Wet hands thoroughly with product and allow to dry without wiping Supervise children in the use of this product
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 or near the eyes or on mucous membranes. In case of contact, rinse thoroughly with water.
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.
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 use and ask a doctor if irritation and redness develop condition persists for more than 72 hours
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 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