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| Product NDC Code | 65517-0035 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pvp-i pouch foil-foil |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SOLUTION | ||||||
| RxCUI drug identifier | 312564 | ||||||
| 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.
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 Pouch foil-foil Povidone-iodine GLYCERIN HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) NONOXYNOL-10 CITRIC ACID MONOHYDRATE 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 - 3/4 oz Pouch Label Dukal Povidone-Iodine 3/4 Fluid Ounce Solution Sterile Antiseptic Drug Facts Active Ingredient Purpose Povidone Iodine USP 10% Antiseptic Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection. Sterile unless package is damaged or opened. 0.75 fl oz (22.5 ml) - 2 - NDC 6551-0035-1 - REF 885 885
Principal Display Panel - 1 oz Pouch Label Dukal Povidone-Iodine 1 Fluid Ounce Solution Sterile Antiseptic Drug Facts Active Ingredient Purpose Povidone Iodine USP 10% Antiseptic Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection. Sterile unless package is damaged or opened. 1 fl oz (29.5 ml) - 2 - NDC 6551-0035-2 - REF 886 886
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.
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. 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.
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