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| Product NDC Code | 63736-040 | ||||
|---|---|---|---|---|---|
| Drug Name | Boil ease |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 244557, 669214 |
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| Application Number | M017 | ||||
| Labeler Name | Insight Pharmaceuticals LLC | ||||
| 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 Benzocaine 20%
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 to affected area no more than 2 times daily Children under 2 years of age Consult a doctor
| Adults and children 2 years of age and older | Apply to affected area no more than 2 times daily |
| Children under 2 years of age | Consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous lanolin, camphor, eucalyptus oil, menthol, petrolatum, thymol, yellow wax
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 and discomfort caused by boils
Purpose
Information about the drug product’s indications for use.Purpose Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.Boil Ease Benzocaine BENZOCAINE BENZOCAINE LANOLIN CAMPHOR (SYNTHETIC) EUCALYPTUS OIL MENTHOL PETROLATUM THYMOL YELLOW WAX
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 28 g Tube Carton BOIL EASE ® PAIN RELIEVING OINTMENT BENZOCAINE 20% NET WT 1 oz (28 g) PRINCIPAL DISPLAY PANEL 28 g Tube Carton BOIL EASE® PAIN RELIEVING OINTMENT BENZOCAINE 20% NET WT 1 oz (28 g)
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.BOIL EASE ® PAIN RELIEVING OINTMENT 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 boils on the lips, nose, cheeks, or forehead
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 for more than 3 days
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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Keep carton for full drug facts
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? call 1-800-344-7239
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 fever occurs redness around the boil develops condition worsens or does not improve symptoms persist for more than 3 days symptoms clear up and occur again within a few days
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
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.Warning For external use only Do not use for more than 3 days Ask a doctor before use if you have boils on the lips, nose, cheeks, or forehead When using this product avoid contact with the eyes Stop use and ask a doctor if fever occurs redness around the boil develops condition worsens or does not improve symptoms persist for more than 3 days symptoms clear up and occur again within a few days Keep out of the 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