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| Product NDC Code | 12258-223 | ||||
|---|---|---|---|---|---|
| Drug Name | Curasore |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1294034, 2109512 |
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| Application Number | part348 | ||||
| Labeler Name | S.S.S. Company | ||||
| 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: Pramoxine Hydrochloride 1%
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 not more than 3 to 4 times daily; avoid moistening area for 2 to 3 minutes following application. Children under 2 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients ethyl alcohol and ethyl ether
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 For the temporary relief of pain and itching associated with fever blisters and cold sores
Purpose
Information about the drug product’s indications for use.Purpose: Local Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Curasore Pramoxine Hydrochloride ALCOHOL ETHER PRAMOXINE HYDROCHLORIDE PRAMOXINE
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 NDC 12258-223-05 CURASORE® Pain Relieving Anesthetic for Fever Blisters • Cold Sores Contains Ether 0.5 FL OZ (15mL) Important: Begin application at the first sign of a fever blister or cold sore. CURASORE® Analgesic-Anesthetic-Antipruritic for Relieving Pain & Itching of Fever Blisters & Cold Sores With DISPOSABLE COTTON APPLICATORS Other Packaging Content Manufactured by S.S.S. Company, Atlanta, GA 30315, USA ssspharmaceuticals.com Rev. E Principal Display Panel
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 FLAMMABLE Keep away from heat, sparks, and open flame Store in a cool place Keep lid tightly capped. To report an adverse event or obtain product information contact (404) 521-0857. Inactive Ingredients ethyl alcohol and ethyl ether
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 In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
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 consult a doctor If Redness Swelling Irritation or pain persists or increases, condition worsens, 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.
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 Do not swallow Avoid contact with the eyes Avoid contact with the nose Stop use and consult a doctor If Redness Swelling Irritation or pain persists or increases, condition worsens, 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.
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 Do not swallow Avoid contact with the eyes Avoid contact with the nose Stop use and consult a doctor If Redness Swelling Irritation or pain persists or increases, condition worsens, 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 the reach of children In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
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