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| Product NDC Code | 67618-150 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Betadine solution |
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| Type | Brand | ||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||
| Dosage Form | SOLUTION | ||||||||||||||||
| 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, 10%(1% 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 single use may prevent extrinsic contamination clean the operative site prior to surgery apply product and allow to dry may be covered with a bandage
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients pareth 25-9, 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 Patient pre-operative skin preparation for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause 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.Betadine Solution POVIDONE-IODINE POVIDONE-IODINE IODINE WATER SODIUM HYDROXIDE C12-15 PARETH-9
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.BetadineSolution 8 oz NDC: 67618-150-09 Betadine Solution 8 oz
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: Avrio Health L.P. Stamford, CT 06901-3431 ©2018, Avrio Health L.P.
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 if you are allergic to povidone-iodine or any other ingredientsin this preparation
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 ControlCenter right away.
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 doctorif irritation, sensitization, or allergic reaction occurs andlasts for 72 hours. These may be signs of a serious condition.
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 single use will reduce the risk of infection from extrinsiccontamination prolonged exposure to wet solution may cause irritationor, rarely, severe skin reactions in pre-operative prepping, avoid “pooling” beneath the patient
Storage and handling
Information about safe storage and handling of the drug product.Other information store in original container store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
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