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| Product NDC Code | 36800-064 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare swimmers ear drops |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | AURICULAR (OTIC) | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 631799 | ||||
| Application Number | M014 | ||||
| Labeler Name | TOPCO ASSOCIATES | ||||
| 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 Isopropyl Alcohol 95% in anhydrous glycerin
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 5 to 5 drops in each affected ear..
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Glycerin
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 Dries water in the ears.
Purpose
Information about the drug product’s indications for use.Purpose Ear drying aid
Spl product data elements
Usually a list of ingredients in a drug product.TopCare Swimmers Ear Drops Isopropyl Alcohol GLYCERIN ISOPROPYL ALCOHOL ISOPROPYL 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 TopCare Swimmers Ear Drops.jpg
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.CVS Ear Drops for Swimmers Drug Facts
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 Ear drainage or discharge. Pain, irritation, or rash in the ear. Have had ear surgery. Dizziness.
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.
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. In case of accidental ingestion, seek professional assistant or contact a Poison Control Center immediately.
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 ask doctor if Irritation (too much burning) or pain occurs.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, ask a health professional before use.
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 Flammable : Keep away from fire and flame. Do not use in the eyes. Ask a doctor before use if you have Ear drainage or discharge. Pain, irritation, or rash in the ear. Have had ear surgery. Dizziness. Stop use and ask doctor if Irritation (too much burning) or pain occurs. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of accidental ingestion, seek professional assistant 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