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| Product NDC Code | 65517-0036 | ||||
|---|---|---|---|---|---|
| Drug Name | Povidone-iodine gel swabstick |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1300277 | ||||
| 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% Purpose Antispetic
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 apply product to skin as needed see product box for additional directions
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients alkyl glucoside, anhydrous citric acid, aonoxynol-10, glycerin, hydroxyethyl cellulose, potassium iodine, 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.Use Antiseptic Skin Preparation
Purpose
Information about the drug product’s indications for use.Purpose Antispetic
Spl product data elements
Usually a list of ingredients in a drug product.Povidone-Iodine Gel Swabstick Povidone Iodine WATER HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) POTASSIUM IODIDE GLYCERIN ANHYDROUS CITRIC ACID SODIUM HYDROXIDE POVIDONE-IODINE IODINE NONOXYNOL-10
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.Dukal Povidone-Iodine Gel Swabstick DUKAL™ CORPORATION NDC 65517-0036-1 REF 899 Hold Upright and Tear Here POVIDONE-IODINE Gel Swabstick Ready Gel 1X™ 4" (10.2cm) Saturated Swabstick Drug Facts Active ingredients Purpose Povidone Iodine USP 10% Antiseptic Use Patient preoperative skin preparation: Helps to reduce bacterial that potentially can cause skin infection 1/Pouch 2 Made in China D07310901 Rev2 item
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.Dukal Povidone-Iodine Gel Swabstick Non-Sterile
Other Information 1% titratable iodine Avoid excessive heat Store at room temperature For hospital or professional use only Not made with natural rubber latex
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 or puncture wounds Serious burn
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 If allergic to Iodine in the 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 Poison Control Center right away
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 infection occurs redness, irritation or swelling develops
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 If allergic to Iodine in the eyes Ask a doctor before use if injuries are deep or puncture wounds Serious burn Stop use and ask doctor if infection occurs redness, irritation or swelling develops Keep out of reach of children If swallowed, get medical help or contact 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