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Pvp iodine - Medication Information

Product NDC Code 50332-0047
Drug Name

Pvp iodine

Type Brand
Active Ingredients
Povidone-iodine .1 g/g
Route TOPICAL
Dosage Form SWAB
RxCUI drug identifier 797730
Application Number part333A
Labeler Name HART Health
Packages
Package NDC Code Description
50332-0047-0 10 packet in 1 box (50332-0047-0) / .35 g in 1 packet
50332-0047-7 100 packet in 1 box (50332-0047-7) / .35 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 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.
Directions Adults and children 12 years of age and over: apply topically to clean affected area 1 to 3 times daily when dry, may be covered with a sterile bandage if gets in eyes, flush thoroughly with water Children under 12 years of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Citric Acid, Glyercin, Nonoxynol, Sodium Hydroxide, 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.
Uses First aid topical antiseptic to help prevent infection in: minor cuts scrapes burns abrasions

Purpose

Information about the drug product’s indications for use.
Purpose Topical Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
PVP Iodine Povidone-Iodine POVIDONE-IODINE IODINE CITRIC ACID ACETATE GLYCERIN NONOXYNOL-9 SODIUM HYDROXIDE WATER

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.
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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 in the eyes or over large portions of the body on serious burns on animal bites on deep or puncture wounds

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 right away 1-800-222-1222

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 symptoms last more than 72 hours redness, swelling, irritation or pain occurs

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