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Product NDC Code | 47593-360 | ||||||||||||||||||
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Drug Name | Ecocare 250 |
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Type | Brand | ||||||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||||||
Dosage Form | SOLUTION | ||||||||||||||||||
RxCUI drug identifier | 260054 | ||||||||||||||||||
Application Number | 505G(a)(3) | ||||||||||||||||||
Labeler Name | Ecolab Inc. | ||||||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Triclosan, 0.3%
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 and forearms dispense a palmful of product to hands scrub hand and forearms for 20 seconds rinse thoroughly and dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: water (aqua), alcohol, potassium cocoate, glycerin, potassium tallowate, tetrasodium edta, cocamidopropyl pg-dimonium chloride phosphate, hydroxyethylcellulose, cocamine oxide, tripotassium phosphate, tetrasodium pyrophosphate, methylparaben, citric acid, tocopheryl acetate, isopropyl alcohol, sodium hydroxide, propylparaben, t-butyl alcohol, phosphoric acid, aloe barbadensis leaf juice, denatonium benzoate, blue 1, yellow 5, sodium benzoate, potassium sorbate
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
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic handwash
Spl product data elements
Usually a list of ingredients in a drug product.EcoCare 250 Triclosan Triclosan Triclosan WATER ALCOHOL POTASSIUM COCOATE TALLOW ACID, BEEF EDETATE SODIUM COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) COCAMINE OXIDE POTASSIUM PHOSPHATE, TRIBASIC SODIUM PYROPHOSPHATE METHYLPARABEN .ALPHA.-TOCOPHEROL ACETATE CITRIC ACID MONOHYDRATE ISOPROPYL ALCOHOL SODIUM HYDROXIDE PROPYLPARABEN TERT-BUTYL ALCOHOL PHOSPHORIC ACID ALOE VERA LEAF DENATONIUM BENZOATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5
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.Representative label and principal display panel ECOLAB EcoCare 250 Hand Cleaner/Sanitizer Active Ingredient: Triclosan 0.3% 1250 mL (42.3 US FL OZ) This product may be patented www.ecolab.com/patents Ecolab Inc. - 1 Ecolab Place - St. Paul, MN 55102 USA - tel. 1 800 392 3392 ©2020 Ecolab USA Inc. - All rights reserved Made in U.S.A. www.ecolab.com - 759401/5303/1220 representative label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask doctor if skin irritation or redness occurs for more than 72 hours
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 eyes
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call 1.800.392.3392
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 if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.Other information for additional information, see Safety Data Sheet (SDS) for emergency medical information in USA and Canada, call 1.800.328.0026. If located outside the United States or Canada, call collect 1.651.222.5352 (number in U.S.)
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 Do not use in eyes When using this product if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop Stop use and ask doctor if skin irritation or redness occurs for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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