Premier Value Cold Sore Treatment
FDA Label NDC 68016-407

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Value for the product Premier Value Cold Sore Treatment (NDC 68016-407). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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