Label: CURASORE- pramoxine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 4, 2020

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  • SPL UNCLASSIFIED SECTION

    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

    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

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CURASORE 
    pramoxine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12258-223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ETHER (UNII: 0F5N573A2Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12258-223-051 in 1 CARTON08/31/1995
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/31/1995
    Labeler - S.S.S. Company (003288321)
    Establishment
    NameAddressID/FEIBusiness Operations
    S.S.S. Company003288321manufacture(12258-223) , pack(12258-223) , label(12258-223)
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