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Product NDC Code | 46414-7777 | ||||||
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Drug Name | Povidone-iodine |
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Type | Generic | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | SOLUTION | ||||||
RxCUI drug identifier | 312564 | ||||||
Application Number | M003 | ||||||
Labeler Name | James Alexander Corporation | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (each swab) 10% Povidone Iodine Solution USP, (1% available Iodine)
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 Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury. Discard after single use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, 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 To treat minor skin cuts and abrasions.
Purpose
Information about the drug product’s indications for use.Purpose Topical Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.POVIDONE-IODINE POVIDONE-IODINE POVIDONE-IODINE IODINE CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS NONOXYNOL-9 SODIUM HYDROXIDE WATER
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.Drug Facts
DISPENSING SOLUTIONS ® JAMES ALEXANDER CORPORATION Blairstown, NJ• (908) 362-9266 Product information and MSDS available on-line at: www.james-alexander.com Void of Aqueous
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 immediately or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at room temperature away from light. Keep from freezing or excessive heat.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-908-362-9266 Monday through Friday, 9:00am - 5:00pm e.s.t.
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. Ask a doctor before use if you have • deep or puncture wounds • serious burns Stop use and ask a doctor if • redness, irritation, swelling or pain persists or increases • infection occurs.
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