Denavir Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.


There is currently no drug history available for this drug.

Other Information

Denavir contains penciclovir, an antiviral agent active against herpes viruses. Denavir is available for topical administration as a 1% white cream. Each gram of Denavir contains 10 mg of penciclovir and the following inactive ingredients: cetomacrogol 1000 BP, cetostearyl alcohol, mineral oil, propylene glycol, purified water and white petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl) butyl]guanine. Its molecular formula is C10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure:

Structure Image

Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP= -1.62).

Denavir Manufacturers

  • Novartis Consumer Health, Inc.
    Denavir (Penciclovir) Cream [Novartis Consumer Health, Inc.]
  • Physicians Total Care, Inc.
    Denavir (Penciclovir) Cream [Physicians Total Care, Inc.]
  • New American Therapeutics, Inc
    Denavir (Penciclovir) Cream [New American Therapeutics, Inc]
  • Remedyrepack Inc.
    Denavir (Penciclovir) Cream [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Denavir (Penciclovir) Cream [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Denavir (Penciclovir) Cream [Remedyrepack Inc. ]
  • Prestium Pharma, Inc.
    Denavir (Penciclovir) Cream [Prestium Pharma, Inc.]

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