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Product NDC Code | 67777-418 | ||||
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Drug Name | Povidone iodine gel swabstick |
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Type | Generic | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 312562 | ||||
Application Number | M003 | ||||
Labeler Name | Dynarex Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Povidone-Iodine 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 • Tear at notch • Remove applicator • Use only once As a first aid antiseptic: • Clean affected area • Apply 1 to 3 times daily • May be covered with a sterile bandage • If bandaged, let dry first For preoperative patient skin preparation: • Clean area • Apply to operative site prior to surgery For Venipuncture skin preparation: • Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inch area, directly over the venipuncture site. Continue this for a minimum of 30 seconds. • After scrubbing for 30 seconds, and using the same applicator, begin at the venipuncture site and move gradually outward in concentric circles to form a total prepped area measuring at least 3 inches in diameter. • Allow site to dry for approximately 30 seconds. • If the patient bend the arm, or if prepared site is touched with the fingers or with any other non-sterile object, the complete preparation must be repeated.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Demineralized Water, Disodium Phosphate Anhydrous, Glycerin, Natrozole HHR
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(s) • For preparation of the skin prior to surgery • First aid to help prevent infection in minor cuts, scrapes, and burns • For venipuncture skin preparation
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.Povidone Iodine Gel Swabstick Povidone Iodine Gel Swabstick POVIDONE-IODINE IODINE GLYCERIN HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 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.Label 1209 Povidone-Iodine Gel Swabstick 1209 BX MASTER
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 you have • Deep or puncture wounds • Animal bites • 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 use • In the eyes or over large areas of the body • Longer than 1 week unless directed by a doctor
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 (800-222-1222) 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 15º-30ºC (59º-86ºF) • Avoid 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 and Comments? 1-888-369-2739 M-F, 9-5 EST
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 Condition persists or gets worse
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 • In the eyes or over large areas of the body • Longer than 1 week unless directed by a doctor Ask a doctor before use if you have • Deep or puncture wounds • Animal bites • Serious burns Stop use and ask a doctor if Condition persists or gets worse Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (800-222-1222) 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