FDA Label for Market Basket Cold Sore Treatment

View Indications, Usage & Precautions

Market Basket Cold Sore Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Demoulas Supermarkets, 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.

Active Ingredient



Benzalkonium Chloride 0.13%


Purpose



Cold Sore/Fever Blister Treatment/First Aid Antiseptic


Uses




  • For treatment of cold sores/fever blisters on the face or lips
  • Helps relieve the symptoms of itching, burning and pain associated with cold sores/fever blisters in just one day
  • Relieves dryness and softens cold sores and 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.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (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
  • 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, Camphor, Cetearylisononanoate, Dipropylenglycole Dicaprylate-Dicaprate, Ethylparaben, Eucalyptus Globulus Leaf Oil, Hexyldecanole, Hexyl Decyl Laurate, Menthol,
Methylparaben, Ozokerite, Phenoxyethanol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Poloxamer 407, Propylparaben, Tocopheryl Nicotinate (Vitamin E), Thymol, 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.


Package Label.Principal Display Panel




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.


* Please review the disclaimer below.