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| Product NDC Code | 64009-336 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Antiseptic hand cleaner |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SOAP | ||||||||
| RxCUI drug identifier | 413257 | ||||||||
| Application Number | 505G(a)(3) | ||||||||
| Labeler Name | Spartan Chemical Company | ||||||||
| 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 Ingredients Chloroxylenol 1.0%
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. Apply a small amount of product (about 5 ml) on hands. Scrub thoroughly for at least 20 seconds. Rinse well and dry hands completely.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Cetrimonium Chloride, Cocamine, Glycerin, Lactic Acid, PEG-120 Methyl Glucose Dioleate, Coco Diisopropanolamide, Sodium Chloride, Fragrance, Styrene/Acrylamide Copolymer, Trisodium Dicarboxymethyl Alaninate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, FD&C Yellow No. 5, FD&C Green No. 3
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 hand washing to decrease bacteria on the skin. Recommended for repeated use.
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.Antiseptic Hand Cleaner Chloroxylenol WATER CETRIMONIUM CHLORIDE COCAMINE GLYCERIN LACTIC ACID, L- PEG-120 METHYL GLUCOSE DIOLEATE COCO DIISOPROPANOLAMIDE SODIUM CHLORIDE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) TRISODIUM DICARBOXYMETHYL ALANINATE, L- .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF FD&C YELLOW NO. 5 FD&C GREEN NO. 3 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.Principal Display Panel - 3.79 Liters Container Label Spartan ® ANTISEPTIC HAND CLEANER TM Germ-fighting formula that meets the hand care needs of institutional and industrial personnel Contains 1.0% Chloroxylenol. Helps decrease bacteria on hands. FOR INSTITUTIONAL AND INDUSTRIAL USE ONLY Formula para combatir microbios que satisface las necesidades de cuidar las manos del personal institucional e industrial. Contiene 1.0% Cloroxilenol. Ayuda a disminuir las bacterias en las manos. PARA USO INSTITUCIONAL E INDUSTRIAL SOLAMENTE Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA NET CONTENTS: 1 U.S. Gallon/3.79 Liters CONTENIDO NETO: 3.79 Litros / 1 Galon EE.UU. #3043 antiseptic
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. 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? 1-800-537-8990
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 doctor if irritation and redness develops, or if condition persists for more than 72 hours.
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 avoid contact with eyes. In case of eye contact, flush eyes with water.
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 When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask doctor if irritation and redness develops, or if condition persists 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