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Product NDC Code | 50332-0056 | ||||
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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 | HART Health | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Povidone Iodine 10% (available iodine 1%)
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 Adults and children 12 years of age and older: r everse cardboard sleeve crush at dot between thumb and forefinger to release fluid gently wipes injured area to clean and disinfect dispose of swab peoperly do not reuse swab Children under 12 years of age: ask a doctor
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 First aid topical antiseptic to help prevent infection in minor cuts scrapes 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 PVPswabv24f.jpg
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 dcotor before use if you have deep or 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 use on animal bits in or near the eyes or over large portions of the body
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. 1-800-222-1222
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 temperaturem 59° - 86°F (15° - 30°C) away from light. Keep from freezing or excessive heat.
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 redness, irritation, swelling or pain persists or increases infection occurs
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 get in eyes
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