FDA Label for Curasore

View Indications, Usage & Precautions

Curasore Product Label

The following document was submitted to the FDA by the labeler of this product S.s.s. Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



DRUG FACTS


Active Ingredient:



Pramoxine Hydrochloride 1%


Purpose:



Local Anesthetic


Uses



For the temporary relief of pain and itching associated with fever blisters and cold sores


Warnings



For external use only


When Using This Product



  • Do not swallow
  • Avoid contact with the eyes
  • Avoid contact with the nose

Otc - Stop Use



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.


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.


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


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


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