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Product NDC Code | 61333-212 | ||||
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Drug Name | Lights povindone iodine swabstick |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SWAB | ||||
RxCUI drug identifier | 797730 | ||||
Application Number | part333C | ||||
Labeler Name | Lights Medical Manufacture Co., 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%) Equivalent to 1% titratable 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.For preparation of the skin prior surgery: clean the affacted area, remove swabstick, apply to the operative site prior to surgery For use as first aid antiseptic: clean the affacted area, apply a small anount of the product to the area 1-3 times daily. Maybe covered with a sterile bandage. If bandaged, let dry first.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Citric acid, disodium phosphate, purified 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: Health care antiseptic for prepapration of skin prior to surgery. First aid antiseptic to help prevent 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.Lights Povindone Iodine Swabstick POVIDONE-IODINE WATER CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE DIBASIC DIHYDRATE 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.image description
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.Discontinue use if irritation and redness develop. Consult a doctor iin case of deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if infection occurs or if condition persists or increases
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 consult a poison control center 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
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 to the eyes *to individuals who are allergic or sensitive to iodine, *over large area of the body, *as first aid antiseptic longer than a week 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