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| Product NDC Code | 13709-312 | ||||
|---|---|---|---|---|---|
| Drug Name | Suavear earwax removal aid |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | AURICULAR (OTIC) | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 702050, 2540674 |
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| Application Number | M014 | ||||
| Labeler Name | NEILMED PHARMACEUTICALS 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 Carbamide Peroxide 6.5%
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 FOR USE IN THE EAR ONLY Adults and children 12 years of age: Tilt head sideways Place 5 to 10 drops into the ear, making sure that the tip of the applicator does not enter the earcanal Keep drops in the ear for sevaral minutes, either by using teh included earplugs or keeping the head tilted to the side Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the enclosed soft silicone bulb Use twice daily for upto four days, or as directed by a doctor Children under 12 years: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Glycerin Oxyquinoline
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 occasional use as an aid to soften, loosen and remove excessive earwax
Purpose
Information about the drug product’s indications for use.Purpose Earwax Removal Aid
Spl product data elements
Usually a list of ingredients in a drug product.SuavEar Earwax Removal Aid Earwax Removal Aid GLYCERIN OXYQUINOLINE CARBAMIDE PEROXIDE HYDROGEN PEROXIDE
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.Product label : SuavEar Earwax Removal Aid Suavear
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 If swallowed, get medical help 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 You need to use for more than 3 days in a row
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 the eyes
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store bottle in the outer carton Product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound. Keep cap on bottle when not in 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 Ask a doctor before use if you have Ear drainage or discharge Ear Pain Irritation or rash in the ear Dizziness An injury or perforation (hole) of the eardrum Recently had ear surgery
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