1. Home
  2. Labeler Index
  3. American Sales Company
  4. 41520-407
  5. Label Information: Careone Cold Sore Treatment

FDA Label for Careone Cold Sore Treatment

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?

Careone Cold Sore Treatment Product Label

The following document was submitted to the FDA by the labeler of this product American Sales 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.

Active Ingredients



Benzalkonium chloride 0.13%

Camphor 3.0%


Purpose



Cold sore/fever blister treatment/first aid antiseptic


Uses



  • •for treatment of cold sores/fever blisters on the face or lips
  • •temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters
  • •first aid to help protect against infection in minor cuts, scrapes, burns, and sores

Warnings



  •  For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.
  •  Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.
  •  When using this product avoid contact with eyes. Use only as directed.
  •  Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor

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 at 1-800-222-1222.


Directions



  • •clean the affected area
  • •apply a small amount of this product to the affected area 1 to 3 times daily
  • •rub in gently
  • •may be covered with a sterile bandage
  • •wash hands before and after applying cream
  • •do not share this product with anyone
  • •children under 12 years of age: ask a doctor

Other Information



store at room temperature


Inactive Ingredients



alcohol, aloe barbadensis leaf juice, arginine, butylparaben, cetearyl isononanoate, dipropylene glycol dicaprylate/dicaprate, ethylparaben, eucalyptus globulus leaf oil, hexyl decyl laurate, hexyldecanole, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, ozokerite, phenoxyethanol, poloxamer 407, propylparaben, thymol, tocopheryl nicotinate (vitamin e), zinc chloride


Questions Or Comments?



Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.
Serious side effects associated with use of this product may be reported to this number.


* Please review the disclaimer below.