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| Product NDC Code | 63736-375 | ||||
|---|---|---|---|---|---|
| Drug Name | Americaine |
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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, 1426293 |
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| Application Number | part346 | ||||
| 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 when practical, cleanse affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product. apply externally to the affected area up to 6 times daily C hildren under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzethonium chloride, polyethylene glycol 300, polyethylene glycol 3350.
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.Uses temporarily relieves these symptoms associated with hemorrhoids inflammation itching local pain soreness
Purpose
Information about the drug product’s indications for use.Purpose Hemorrhoidal Ointment
Spl product data elements
Usually a list of ingredients in a drug product.Americaine Benzocaine BENZOCAINE BENZOCAINE BENZETHONIUM CHLORIDE POLYETHYLENE GLYCOL 300 POLYETHYLENE GLYCOL 3350 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.PRINCIPAL DISPLAY PANEL: Americaine ® Benzocaine Hemorrhoidal Ointment NET WT. 1 OZ (28 G) PRINCIPAL DISPLAY PANEL: Americaine® Benzocaine Hemorrhoidal Ointment 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.Drug Facts
Other i nformation if ointment contacts clothing or other fabrics, wash in warm water only; do not use bleach. store at room temperature 15°– 25°C (59°– 77°F) tube is sealed for your protection. Do not use if foil seal is broken or missing.
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? Call 1-800-344-7239 or visit our website at www.insightpharma.com Distributed by: Insight Pharmaceuticals LLC Tarrytown, NY 10591 A Prestige Brands Company
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 condition worsens or does not improve in 7 days bleeding occurs symptoms do not get better, or if redness, irritation, swelling, pain or other symptoms occur or increase
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 certain persons can develop allergic reactions to ingredients in this product do not put this product into the rectum by using fingers or any mechanical device or applicator do not exceed dosage unless directed by a doctor
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 For external use only When using this product certain persons can develop allergic reactions to ingredients in this product do not put this product into the rectum by using fingers or any mechanical device or applicator do not exceed dosage unless directed by a doctor Stop use and ask a doctor if condition worsens or does not improve in 7 days bleeding occurs symptoms do not get better, or if redness, irritation, swelling, pain or other symptoms occur or increase 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