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Povidone iodine - Medication Information

Product NDC Code 0904-1103
Drug Name

Povidone iodine

Type Generic
Active Ingredients
Povidone-iodine 100 mg/ml
Route TOPICAL
Dosage Form SOLUTION
RxCUI drug identifier 312564
Application Number M003
Labeler Name Major Pharmaceuticals
Packages
Package NDC Code Description
0904-1103-09 237 ml in 1 bottle (0904-1103-09)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Active Ingredient Purpose Povidone Iodine 10% v/v Antiseptic

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 As a first aid antiseptic clean affected area apply a small amount of this product to the area1 to 3 times daily may be covered with a sterile bandage, if bandaged let dry. For preoperative patient skin preparation clean area apply to operative site prior to surgery using the applicator

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient citric acid glycerin sodium citrate tween 80 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.
For use as an first aid antiseptic pre-operative skin preperation

Purpose

Information about the drug product’s indications for use.
Uses First aid antiseptic to help prevent infection in minor cuts, scrapes and burns. Healthcare antiseptic for preparation of the skin prior to surgery. Antiseptic cleanser for preparation of skin prior to an infection.

Spl product data elements

Usually a list of ingredients in a drug product.
povidone iodine povidone iodine CITRIC ACID MONOHYDRATE WATER GLYCERIN SODIUM CITRATE POLYSORBATE 80 SODIUM PHOSPHATE 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.
Principal Display Panel Povidone Iodine

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 puncture wounds Animal bites Serious burns

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 As a first aid antiseptic for more than 1 week unless directed by a doctor. In the eyes. Over large areas of the body. On individuals who are allergic or sensitive to iodine.

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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

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 If irritation and redness develop If condition persists for more than 72 hours, consult a physician.

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

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