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| Product NDC Code | 65517-0039 | ||||
|---|---|---|---|---|---|
| Drug Name | Pvp-i prep pads paper-foil |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SWAB | ||||
| Application Number | M003 | ||||
| Labeler Name | Dukal LLC | ||||
| 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: Povidone Iodine USP 10%
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: Clean the area. Apply product to the operative site prior to surgery using pad to prep desired area.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified 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.Use: For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.
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.PVP-I Prep Pads paper-foil Povidone-iodine GLYCERIN HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) NONOXYNOL-10 ANHYDROUS CITRIC ACID SODIUM HYDROXIDE WATER C12-20 ALKYL GLUCOSIDE POTASSIUM IODIDE POVIDONE-IODINE IODINE
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 - PVP-I Prep Pads Paper/Foil Pouch Label Dukal Povidone-Iodine Prep Pad Non-Sterile Antiseptic For Professional and Hospital Use Not Made with Natural Rubber Latex Manufactured For: Dukal LLC 1(800)243-0741 / Ronkonkoma, NY 11779 Made in China Dukal is a trademark registered in the US Patent & Trademark Office by Dukal, LLC 1 Per Pouch / 2 / NDC 65517-0039-1 / REF 914 914 Item
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.Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
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 apply to persons allergic to iodine. Do not use in the eyes. Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns. Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs. Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation. Keep out of reach of children If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
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 or gets in eyes, get medical help 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: 1% titratable iodine, for hospital or professional use only. Store at ambient temperatures.
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, infection occurs. Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.
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.
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