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| Product NDC Code | 67618-151 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Betadine surgical scrub |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | SOLUTION | ||||||||||||
| RxCUI drug identifier | 211747, 1149658 |
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| Application Number | M003 | ||||||||||||
| Labeler Name | Atlantis Consumer Healthcare, 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.Drug Facts Active ingredient Povidone-iodine, 7.5%(0.75% available 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 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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ammonium nonoxynol-4sulfate, 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 helps to reduce bacteria that potentially can cause skininfection for handwashing to reduce bacteria on the skin significantly reduces the number of microorganisms on thehands and forearms prior to surgery or patient care
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic Uses helps to reduce bacteria that potentially can cause skininfection for handwashing to reduce bacteria on the skin significantly reduces the number of microorganisms on thehands and forearms prior to surgery or patient care
Spl product data elements
Usually a list of ingredients in a drug product.Betadine Surgical Scrub 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.Betadine Surgical Scrub NDC 67618-151-17 NDC 67618-150-17
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Dist. by: AvrioHealth L.P. Stamford, CT 06901-3431 304954-0A
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.Stop use and ask a doctor if irritation and redness develop in rare instances of local irritation or sensitivity
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 this product in the eyes
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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F) store in original container
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 this product in the eyes When using this product prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions 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