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| Product NDC Code | 67618-153 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Betadine solution swabsticks |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SOLUTION | ||||||
| RxCUI drug identifier | 797730, 798176 |
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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.Active ingredient Purpose Povidone-iodine Solution USP, 10% (equal to1% 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 tear at slit; pull top of packette across, exposing endof swabstick remove Betadine Solution Swabstick and apply as needed use one time only
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients purified water, sodium hydroxide Dist. by: Avrio Health L.P. Stamford, CT 06901-3431
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 skin prior to surgery helps reduce bacteria that can potentially 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 Swabsticks POVIDONE-IODINE POVIDONE-IODINE IODINE SODIUM HYDROXIDE WATER
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.BetadineSwabsticks — 1 Swab NDC: 67618-153-01 BetadineSwabsticks — 3 Swabs 67618-153-03 NDC 67618-153-01 NDC 67618-153-03
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 if you are allergic to iodine or other product ingredients
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 ofchildren. Ifswallowed, get medical help or contact a Poison Control Center rightaway
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 using this product in rare instances of local irritation or sensitivity if irritation and redness develop and continue for morethan 72 hours
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 may cause irritation or, rarely, severeskin reactions
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Other information store between 20˚-25˚C (68˚-77˚F).Avoid freezing and excessive heat above 40˚C (104˚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