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Product NDC Code | 49348-711 | ||||
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Drug Name | Sunmark iodides tincture |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
Application Number | M003 | ||||
Labeler Name | Strategic Sourcing Services LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl Alcohol 48%
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. apply a small amount on the area 1 to 3 times 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 ingredient s ammonium hydroxide, iodine, potassium iodide, and purified water
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.Use first aid to help prevent infection in minor cuts, scrapes and 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.Sunmark Iodides Tincture Ethyl Alcohol WATER AMMONIA IODINE POTASSIUM IODIDE ALCOHOL ALCOHOL
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 Label 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.Drug Facts
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 Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at room temperature
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 consult doctor if the condition persists or gets worse. Do not use this product for longer than 1 week unless directed by a doctor.
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 use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
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 Flammable, keep away from fire or flame When using this product do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. Stop use and consult doctor if the condition persists or gets worse. Do not use this product for longer than 1 week unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help 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