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| Product NDC Code | 72429-0003 | ||||
|---|---|---|---|---|---|
| Drug Name | Ear pain md unit dose |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 2595042 | ||||
| Application Number | M017 | ||||
| Labeler Name | Eosera, 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 Lidocaine HCL Monohydrate 4%
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 Adults and children 2 years of age and older Apply 2 to 3 drops to the affected area not more than 3 to 4 times daily. For children under 2 DO NOT USE, consult a doctor.
| Adults and children 2 years of age and older | Apply 2 to 3 drops to the affected area not more than 3 to 4 times daily. |
| For children under 2 | DO NOT USE, consult a doctor. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe barbadensis (Aloe), Benzalkonium chloride, Benzyl alcohol, Hypromellose (HPMC), Water. May contain Hydrochloric acid and/or Sodium hydroxide to adjust pH.
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 for the temporary relief of pain.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Ear Pain MD Unit Dose LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS Benzalkonium Chloride Benzyl Alcohol Sodium Acetate Anhydrous ACETIC ACID Water
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 - 10 Vial Carton eosera ® EAR PAIN MD ® PAIN RELIEVING DROPS #1 DOCTOR RECOMMENDED* With 4% LIDOCAINE 10 sigle use vials 10 vials [0.5 mL each] PRINCIPAL DISPLAY PANEL - 10 Vial Carton
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
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 large quantities, particularly over raw skin surfaces or blistered areas. if you are allergic to any ingredient in this product. if you have an injury or perforation (hole) of the eardrum, including tubes in the ear. If conditions worsen, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 844-732-7929 (M-F 9:00am – 5:00pm CST)
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 Keep out of reach of children. For external use only. If swallowed, immediately call Poison Control 800-222-1222 Avoid contact with the eyes. Do not use in large quantities, particularly over raw skin surfaces or blistered areas. if you are allergic to any ingredient in this product. if you have an injury or perforation (hole) of the eardrum, including tubes in the ear. If conditions worsen, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
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