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| Product NDC Code | 67618-160 | ||||
|---|---|---|---|---|---|
| Drug Name | Betadine |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 108204, 238850 |
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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 ingredients Povidone-iodine, 5%(0.5% 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 clean the affected area spray a small amount of the product on the area 1 to 3 timesa daily may be covered with sterile bandage if bandaged, let dry first
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, disodium phosphate, glycerin,poloxamer 407, potassium iodate, 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 First aidto help prevent infection in minor cuts scrapes burns
Purpose
Information about the drug product’s indications for use.Purpose First aid Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Betadine POVIDONE-IODINE POVIDONE-IODINE IODINE CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE GLYCERIN POLOXAMER 407 POTASSIUM IODATE WATER SODIUM HYDROXIDE Betadine Spray
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 3oz Spray NDC: 67618-160-03
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
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 a doctor before useif you have deep or puncture wounds serious burns animal bites
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 over large areas of the body 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 Control Centerright 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 if the condition persists or gets worse you need to use this product for more than 1 week
Storage and handling
Information about safe storage and handling of the drug product.Other information store at25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do NotFreeze
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