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| Product NDC Code | 0116-0151 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Betadine |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| Application Number | M003 | ||||||
| Labeler Name | Xttrium Laboratories, Inc. | ||||||
| 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, 7.5%
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 A. Surgical hand scrub: wet hands with water spread about 5 cc (1 teaspoonful) of Scrub over both handsand forearms without adding more water, scrub thoroughly for 2 1/2 to3 minutes use a sponge if desired. Clean thoroughly under fingernails. add a little water and develop copious suds. Rinse thoroughlyunder running water. repeat the entire procedure using another 5 cc of Scrub B. Antiseptic hand wash: wet hands with water and pour about 5 cc of Scrub on hands rub hands vigorously together for at least 15 seconds, coveringall surfaces rinse and dry with a disposable towel C. Patient pre-operative skin preparation: ■ single use only ■ wet skin with water ■ apply Scrub (1 cc is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about 5 minutes ■ rinse off using sterile gauze saturated with water ■ the area may then be painted with BETADINE Solution and allowed to dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients ammonium nonxynol-4 sulfate, nonoxynol-9, 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.Uses ■ for preparation of the skin prior to surgery ■ helps to reduce bacteria that potentially can cause skin infection ■ for handwashing to reduce bacteria on the skin ■ significantly reduces the number of microorganisms on the hands forearms prior to surgery or patient care
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.Betadine Povidone-Iodine POVIDONE-IODINE IODINE AMMONIUM NONOXYNOL-4 SULFATE NONOXYNOL-9 WATER SODIUM HYDROXIDE
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.7.5% Betadine Surgical 4oz 7.5% Betadine surgical 1 gallon
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.■ store at 25'C (77'F); excursions permitted between 15'-30'C (59'-86'F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-833-288-2684
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 When using this product ■ prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions ■ in pre-operative prepping, avoid "pooling" beneath the patient Stop use and ask a doctor ■ if irritation and redness develop ■ in rare instances of local irritation or sensitivity Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away
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