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| Product NDC Code | 0904-1102 | ||||
|---|---|---|---|---|---|
| Drug Name | Major povidone iodine |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| Application Number | M005 | ||||
| Labeler Name | Major Pharmaceuticals | ||||
| 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 Povidone Iodine USP10% w/w (available iodine 1%)
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 apply directly to affected area may be bandaged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycerin, PEG-6, PEG-32, propylene glycol
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 the treatment of: minor wounds infections kills bacteria promptly
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic-germicidal
Spl product data elements
Usually a list of ingredients in a drug product.Major Povidone Iodine POVIDONE-IODINE POVIDONE-IODINE IODINE GLYCERIN POLYETHYLENE GLYCOL 300 POLYETHYLENE GLYCOL 1500 PROPYLENE GLYCOL
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.Principal Display Panel – 1 oz. Tube Major ® NDC 0904-1102-31 Povidine™ FIRST AID OINTMENT NET WT. 1 OZ (28.35 g) *Compare to POVIDINE – IODINE 10% Active Ingredient of AVAILABLE IODINE 1% Betadine® Ointment Principal Display Panel – 1 oz. Tube
Principal Display Panel – 1 oz. Carton Major ® NDC 0904-1102-31 Povidine™ *Compare to FIRST AID OINTMENT Active Ingredient of NET WT. 1OZ (28.35 g) POVIDINE - IODINE 10% Betadine® Ointment Principal Display Panel – 1 oz. Carton
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.DRUG FACTS
Other information Store at controlled room temperature 15°-30°C (59°-86°F). Close cap tightly after use. For control no. and expiration date, see carton and/or crimp of tube. Will not stain natural fabrics. Protect from freezing.
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 animal bites serious burns
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 over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor
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 this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Adverse Drug Event call (800)616-2471 Dist. By MAJOR PHARMACEUTICALS 31778 Enterprise Drive, Livonia, Ml 48150 USA Re-Oder No. 100433 M-101
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 redness, irritation or swelling occurs or pain persists
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 Avoid contact with eyes.
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. Do not use over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor When using this product Avoid contact with eyes. Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if redness, irritation or swelling occurs or pain persists Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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