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First aid only povidone-iodine antiseptic - Medication Information

Product NDC Code 0924-8112
Drug Name

First aid only povidone-iodine antiseptic

Type Brand
Active Ingredients
Povidone-iodine 1 g/100ml
Route TOPICAL
Dosage Form SWAB
RxCUI drug identifier 797730
Application Number M003
Labeler Name Acme United Corporation
Packages
Package NDC Code Description
0924-8112-00 .5 ml in 1 pouch (0924-8112-00)
0924-8112-01 10 pouch in 1 carton (0924-8112-01) / .5 ml in 1 pouch
0924-8112-02 50 pouch in 1 carton (0924-8112-02) / .5 ml in 1 pouch
0924-8112-03 100 pouch in 1 carton (0924-8112-03) / .5 ml in 1 pouch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient: Povidone-Iodine Solution 10%

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: Open packet and wipe affected area. Apply 1 to 3 times daily. May be 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 s: alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

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: First aid antiseptic to help prevent skin infection.

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.
First Aid Only Povidone-Iodine Antiseptic Povidone-iodine GLYCERIN HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) NONOXYNOL-10 ANHYDROUS CITRIC ACID SODIUM HYDROXIDE WATER POTASSIUM IODIDE 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.
Carton Label Image

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 doctor before use if you have ▪ deep or 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 ▪ in eyes ▪ over large areas of the body ▪ if allergic to any of the ingredients ▪ longer than 1 week unless directed by a doctor. Ask doctor before use if you have ▪ deep or puncture wounds ▪ animal bites ▪ serious burns. Stop use and ask a doctor if ▪ conditions worsen or clear up and then recur ▪ the condition persists for more than 7 days Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.

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 the reach of children. If swallowed get medical help or contact 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..

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 ▪ conditions worsen or clear up and then recur ▪ the condition persists for more than 7 days

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