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Product NDC Code | 73117-111 | ||||||||||
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Drug Name | Cleanse right ear wax drops |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | IRRIGATION | ||||||||||
Dosage Form | SOLUTION/ DROPS | ||||||||||
RxCUI drug identifier | 702050 | ||||||||||
Application Number | M014 | ||||||||||
Labeler Name | Blue Echo Care | ||||||||||
Packages |
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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 over 12 years of age: Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Citric Acid, Sodium Citrate Dihyfrate, Sodium Lauryl Sulfate, Glycerin, Propylene Glycol, 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.Directions FOR USE IN THE EAR ONLY Adults and children over 12 years of age: Tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal. Children under 12 years: consult a doctor.
Purpose
Information about the drug product’s indications for use.Purpose Ear Wax Removal Aid
Spl product data elements
Usually a list of ingredients in a drug product.Cleanse Right Ear Wax Drops Ear Wax Drops SODIUM LAURYL SULFATE PROPYLENE GLYCOL CARBAMIDE PEROXIDE HYDROGEN PEROXIDE GLYCERIN SODIUM CITRATE ANHYDROUS CITRIC ACID
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.Carbamide Peroxide 6.5
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 the reach of children If swallowed, get medical help or contact a Poison Control Center right away.
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 eardrainage, discharge, ear pain,irritation rash in the ear,or are dizzy injury or perforation (hole) of the ear drum 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