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| Product NDC Code | 67777-002 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Povidone iodine prep pad |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SWAB | ||||||
| RxCUI drug identifier | 797730 | ||||||
| Application Number | M003 | ||||||
| Labeler Name | Dynarex Corporation | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Povidone-Iodine USP 10% w/v (9.85% w/w)
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 prep pad Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage If bandaged, let dry first Use only once
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Anhydrous Citric Acid, Glycerin, Polysorbate 80, Sodium Citrate, Sodium Phosphate Dibasic, 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(s) First aid to help prevent the risk of infection in minor cuts, scrapes, and burns
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Povidone Iodine Prep Pad Antiseptic GLYCERIN WATER POLYSORBATE 80 SODIUM CITRATE POVIDONE-IODINE IODINE SODIUM PHOSPHATE, DIBASIC ANHYDROUS CITRIC ACID
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 Povidone-Iodine Prep Pads
Label Povidon Iodine Prep Pad 1108 BX MASTER
Label 1108UB-10 1108UB-10 1108UB-10_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
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 (1-800-222-1222) 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.Stop use and ask a doctor if • Condition persists or gets worse
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature 15º-30ºC (59º-86ºF) Flammable. Keep away from fire or flame
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 one 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 (1-800-222-1222) right away.
Do not use • In the eyes or over large areas of the body • Longer than one 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