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| Product NDC Code | 0395-9128 | ||||
|---|---|---|---|---|---|
| Drug Name | Povidone iodine |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 314935 | ||||
| Application Number | M003 | ||||
| Labeler Name | Humco Holding Group, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Povidone-Iodine 0.5% (0.05% available iodine)
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 DO NOT SWALLOW Adults and children 12 years and older: Gargle with 10mL full strength for 30 seconds, then spit out. Use only with dosing cup provided. Use up to 4 times daily. Children under 12: Do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Citric acid, flavor, glycerin, propylene glycol, purified water, saccarin sodium, sodium hydroxide.
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 the temporary relief of occasional sore throat.
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 Povidone Iodine Gargle 0.5% MENTHOL SACCHARIN SODIUM ANHYDROUS CITRIC ACID GLYCERIN SODIUM HYDROXIDE WATER PROPYLENE GLYCOL PEPPERMINT 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.Purdue Gargle Label Gargle Label 2022 Gargle IFC 2022 Gargle Label.jpg Gargle.jpg
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.Drug Facts
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 this product For more than 7 days unless directed by a dentist or doctor. If you are allergic to povidone-iodine or any other ingredients in this product. If you have any thyroid conditions.
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. In case more than used for gargling is swallowed, get medical help or contact a Poison Control Center immediately.
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 25°C (77°F); Excursions permitted between 15°C and 30°C (59°F-86°F). May stain clothing or dental work. Avoid contact with jewelry, especially silver.
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 consult a doctor if Symptoms do not improve in 7 days. Irritation, pain or redness persists or worsens. Swelling, rash or fever develops.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not Get into eyes. If contact occurs, rinse eyes thoroughly with water. If iritation persists, consult a doctor. Swallow. Use with hydrogen peroxide.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding Ask a health professional before use.
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 Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and voniting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.
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