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| Product NDC Code | 72429-0002 | ||||
|---|---|---|---|---|---|
| Drug Name | Ear pain md for kids |
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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 and over Apply 2 to 3 drops to affected area not more than 3 to 4 times daily. Children under 2 years Consult a doctor.
| Adults and children 2 years and over | Apply 2 to 3 drops to affected area not more than 3 to 4 times daily. |
| Children under 2 years | 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 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS ALOE VERA LEAF Benzyl Alcohol Benzalkonium Chloride HYPROMELLOSE, UNSPECIFIED Water Ear Pain MD for Kids LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS ALOE VERA LEAF Benzyl Alcohol Benzalkonium Chloride HYPROMELLOSE, UNSPECIFIED 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 - 12.5 mL Bottle Carton EAR PAIN MD ® Pain Relieving Drops with 4% LIDOCAINE 0.42 fl oz (12.5 mL) PRINCIPAL DISPLAY PANEL - 12.5 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 12.5 mL Bottle Carton - Kids EAR PAIN MD ® Pain Relieving Drops with 4% LIDOCAINE 0.42 fl oz (12.5 mL) PRINCIPAL DISPLAY PANEL - 12.5 mL Bottle Carton - Kids
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
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.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.
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 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 or tubes in the ear.
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 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 or 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