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| Product NDC Code | 67618-182 | ||||
|---|---|---|---|---|---|
| Drug Name | Betadine antiseptic oral rinse |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| Application Number | part356 | ||||
| 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, 0.5% (0.05% 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 Use full strength Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out. Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out. With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, flavor, glycerin, propylene glycol, purified water, saccharin sodium, 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 oral mucosa prior to injection, dental surgery, or tooth extraction
Purpose
Information about the drug product’s indications for use.Purpose Oral Antiseptic Uses For preparation of the oral mucosa prior to injection, dental surgery, or tooth extraction
Spl product data elements
Usually a list of ingredients in a drug product.BETADINE Antiseptic Oral Rinse POVIDONE-IODINE POVIDONE-IODINE IODINE GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM HYDROXIDE ANHYDROUS CITRIC ACID
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 Oral Rinse NDC: 67618-182-08 Betadine Oral Rinse label
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 305765-0B
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 for more than 7 days unless directed by a dentist or doctor in children under 12 years of age unless directed by a dentist or doctor if you are allergic to povidone-iodine or any other ingredients in this product if you have any thyroid conditions
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. In case more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center 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 doctor or dentist if symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops
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 do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor do not swallow do not use with hydrogen peroxide
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) may stain clothing or dental work avoid contact with jewelry, especially silver
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 Do not use this product for more than 7 days unless directed by a dentist or doctor in children under 12 years of age unless directed by a dentist or doctor if you are allergic to povidone-iodine or any other ingredients in this product if you have any thyroid conditions When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor do not swallow do not use with hydrogen peroxide Stop use and ask a doctor or dentist if symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops
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