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| Product NDC Code | 63029-323 | ||||
|---|---|---|---|---|---|
| Drug Name | Debrox swimmers ear |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | AURICULAR (OTIC) | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 631799 | ||||
| Application Number | part344 | ||||
| Labeler Name | Medtech Products 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
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 unscrew cap from bottle remove foil safety seal from bottle affix applicator cap to bottle remove red applicator cap tip apply 4 to 5 drops in each affected ear
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive 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 and relieves water-clogged ears after swimming showering bathing washing the hair
Purpose
Information about the drug product’s indications for use.Purpose Isopropyl alcohol 95% in an anhydrous glycerin 5% base ....Ear drying aid
Spl product data elements
Usually a list of ingredients in a drug product.Debrox Swimmers Ear isopropyl alcohol ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL GLYCERIN CLEAR
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.P RINCIPAL D ISPLAY P ANEL Debrox ® Swimmer’s Ear Isopropyl alcohol 95% Ear Drying Drops 1 FL OZ (30 mL) PRINCIPAL DISPLAY PANEL Debrox ® Swimmer’s Ear Isopropyl alcohol 95% Ear Drying Drops 1 FL OZ (30 mL)
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 recap bottle after each use keep away from head or direct sunlight store at room temperature 15-25ºC (59-77ºF) do not use if foil seal imprinted with “SEALED FOR YOUR PROTECTION” under cap is broken or missing keep carton for full 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 • ear pain, irritation or rash in the ear • dizziness • recently had ear surgery
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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-344-7239 debrox.com
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 irritation (too much burning) or pain occurs
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.W arnings Flammable: Keep away from fire or flame Do not use in the eyes Ask a doctor before use if you have • ear drainage or discharge • ear pain, irritation or rash in the ear • dizziness • recently had ear surgery Stop use and ask a doctor if irritation (too much burning) or pain occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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