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Povidone iodine prep pad - Medication Information

Product NDC Code 67777-002
Drug Name

Povidone iodine prep pad

Type Brand
Active Ingredients
Povidone-iodine 10 g/100g
Route TOPICAL
Dosage Form SWAB
RxCUI drug identifier 797730
Application Number M003
Labeler Name Dynarex Corporation
Packages
Package NDC Code Description
67777-002-01 1000 box in 1 case (67777-002-01) / 100 packet in 1 box (67777-002-02) / .3 g in 1 packet
67777-002-03 1000 box in 1 case (67777-002-03) / 10 packet in 1 box (67777-002-04) / .3 g in 1 packet
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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 USP, 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