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| Product NDC Code | 50685-009 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Good care povidone iodine swabsticks |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SWAB | ||||||||
| RxCUI drug identifier | 797730 | ||||||||
| Application Number | part333E | ||||||||
| Labeler Name | Dalian Goodwood Medical Care Ltd. | ||||||||
| Packages |
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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 For preparation of the skin prior to surgery clean the affected area, remove swab by stick, apply to the operative site prior to surgery For use as a first aid antiseptic clean the affected area, apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Purified water, Povidone Iodine, Citric Acid Disodium Hydrogen Phosphate Dodecahydrate Potassium Iodate Nonoxynol
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 Health-care antiseptic for preparation of the skin prior to surgery First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns
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.Good Care Povidone Iodine Swabsticks POVIDONE-IODINE WATER CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE POTASSIUM IODATE 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.Good Care Povidone Iodine, USP Swabsticks (1s) (50 pouches/box) (50685-009-01) PovidoneIodine1s50pouchesbox PovidoneIodine1s
Good Care Povidone Iodine, USP Swabsticks (2s) (25 pouches/box) (50685-009-02) PovidoneIodine2s25pouchesbox PovidoneIodine2s
Good Care Povidone Iodine, USP Swabsticks (3s) (25 pouches/box) (50685-009-03) PovidoneIodine3s PovidoneIodine3s25pouchesbox
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.Good Care Povidone Iodine, USP Swabsticks
Manufactured by Dalian Goodwood Medical Care Ltd. Made in China
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 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.Discontinue use if irritation and redness develop. Consult a doctor in case of deep or puncture wounds, animal bites, serious burns. Stop use and consult a doctor if the condition persists or gets worse.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)
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 or apply in the eyes on individuals who are allergic or sensitive to iodine over large areas of the body as a first aid antiseptic longer than 1 week unless directed by a doctor Discontinue use if irritation and redness develop. Consult a doctor in case of deep or puncture wounds, animal bites, serious burns. Stop use and consult a doctor if the condition persists or gets worse. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control 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