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| Product NDC Code | 67618-165 | ||||
|---|---|---|---|---|---|
| Drug Name | Betadine dry powder |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, SPRAY | ||||
| RxCUI drug identifier | 153060, 2374358 |
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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,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 SHAKE WELL BEFORE USE Hold can approximately 6 inches from wound and apply a thinlayer over affected area 1 to 3 daily May be covered with a sterile bandage
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Isobutane,isopropyl myristate, pentrane, propane
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 aidantiseptic Uses First aidto help prevent infection in minor cuts scrapes burns
Spl product data elements
Usually a list of ingredients in a drug product.Betadine Dry Powder POVIDONE-IODINE POVIDONE-IODINE IODINE ISOBUTANE ISOPROPYL MYRISTATE PROPANE METHOXYFLURANE Betadine Dry Powder 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.BetadineDry Powder Spray NDC: 67618-165-01
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 305653-0A
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.Ask a doctor before use if 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 or near 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 reachof children. If swallowed, get medicalhelp 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 if the condition persists or gets worse you need to use this product for more than 1 week
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 thoroughlywith water. If irritation persists, consult a doctor.
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)
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 Extremely Flammable Do not use near heat, flame or while smoking. Do notpuncture or incinerate. Contents under pressure. Do not store at temperaturesabove 120⁰F. Intentional misuse by deliberately concentrating andinhaling the contents can be harmful or fatal Do not use in or near eyes over large areas of the body if you are allergic to povidone-iodine or any other ingredientsin this preparation When using this product do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor. Ask a doctor before use if you have deep or puncture wounds serious burns animal bites Stop use and ask a doctor if the condition persists or gets worse you need to use this product for more than 1 week Keep out of reachof children. If swallowed, get medicalhelp 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