FDA Label for Carmex Cold Sore Treatment External Analgesic

View Indications, Usage & Precautions

Carmex Cold Sore Treatment External Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Carma Laboratories, Inc.. 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.

Carmex Cold Sore Treatment External Analgesic




Active Ingredient



Benzocaine 10%


Purpose



External Analgesic / Anti-Itch


Uses



  • For the temporary relief of symptoms of cold sores and fever blisters

Warnings



  • For external use only
  • Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics
  • When using this product keep out of eyes. Rinse with water to remove.
  • Do not exceed recommended dosage.
  • Stop use and ask a doctor or dentist if
    • cold sore symptoms do not improve in 7 days
      • irritation, pain, or redness persists or worsens
      • swelling, rash, or fever develops


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • adults and children 2 years of age and older: apply to affected area (lips) not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor

Inactive Ingredients



cyclomethicone, polyethylene glycol 600, dimethicone, silica, petrolatum, phenyl trimethicone, PEG/PPG-19/19 dimethicone, mica, peg 12 dimethicone, titanium dioxide, polyurethane-40, menthol, tin oxide


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