Included as part of the PRECAUTIONS section.
ZOVIRAX Cream should only be applied on the affected external
aspects of the lips and face in patients with herpes labialis. Because no data
are available, application to human mucous membranes is not recommended.
ZOVIRAX Cream is intended for cutaneous use only and should not be used in the
eye or inside the mouth or nose.
ZOVIRAX Cream has a potential for irritation and contact
sensitization [see ADVERSE REACTIONS].
The effect of ZOVIRAX Cream has not been established in
Patient Counseling Information
Advise the patient to read the FDA-approved patient
labeling (PATIENT INFORMATION).
Patients should be informed that ZOVIRAX Cream is a
prescription topical cream for the treatment of cold sores (recurrent herpes
labialis) that occur on the face and lips. ZOVIRAX Cream is not a cure for cold
sores. Patients should be instructed that ZOVIRAX Cream is intended for
cutaneous use only for herpes labialis of the lips and around the mouth.
Patients should be advised that ZOVIRAX Cream should not be used in the eye,
inside the mouth or nose, or on the genitals. Patients should be instructed to
avoid applying other topical products to the affected area while using ZOVIRAX
Do not use if you are allergic to ZOVIRAX Cream or any of
the ingredients in ZOVIRAX Cream. Before you use ZOVIRAX Cream, tell your
doctor if you are pregnant, planning to become pregnant, or are breast-feeding.
Instructions for Use
Treatment should be initiated at the earliest sign or
symptom of recurrence. Patients should be instructed to wash hands prior to
application and ensure the face and/or lips are clean and dry. Patients should
be advised to apply ZOVIRAX Cream topically five times per day for four days.
Patients should be instructed to topically apply a quantity of ZOVIRAX Cream
sufficient to cover the affected area, including the outer margin. Patients
should be advised to avoid unnecessary rubbing of the affected area to avoid
aggravating or transferring the infection. Patients should be instructed to
wash their hands with soap and water after using ZOVIRAX Cream. Keep out of
reach of children.
Possible Side Effects
Common skin-related side effects that occurred when
ZOVIRAX Cream was applied include application site reactions. ZOVIRAX Cream has
the potential for irritation and contact sensitization.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Systemic exposure following topical administration of
acyclovir is minimal. Dermal carcinogenicity studies were not conducted.
Results from the studies of carcinogenesis, mutagenesis and fertility are not
included in the full prescribing information for ZOVIRAX Cream due to the
minimal exposures of acyclovir that result from dermal application. Information
on these studies is available in the full prescribing information for ZOVIRAX
Capsules, Tablets, and Suspension and ZOVIRAX for Injection.
Use In Specific Populations
Pregnancy Category B
There are no adequate and well-controlled studies of
acyclovir cream in pregnant women. Acyclovir cream should be used during
pregnancy only if the potential benefit justifies the potential risk to the
Acyclovir was not teratogenic in the mouse, rabbit, or
rat at exposures greatly in excess of human exposure.
It is not known whether topically applied acyclovir is
excreted in breast milk. Systemic exposure following topical administration is
However, after oral administration of ZOVIRAX, acyclovir
concentrations have been documented in breast milk in two women and ranged from
0.6 to 4.1 times the corresponding plasma levels. These concentrations would
potentially expose the nursing infant to a dose of acyclovir up to 0.3
mg/kg/day. Nursing mothers who have active herpetic lesions near or on the
breast should avoid nursing.
An open-label, uncontrolled trial with ZOVIRAX Cream 5%
was conducted in 113 patients aged 12 to 17 years with recurrent herpes
labialis. In this trial, therapy was applied using the same dosing regimen as
in adults and subjects were followed for adverse events. The safety profile was
similar to that observed in adults. Safety and effectiveness in pediatric
patients less than 12 years of age have not been established.
Clinical studies of acyclovir cream did not include
sufficient numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger
patients. Systemic absorption of acyclovir after topical administration is
minimal [see CLINICAL PHARMACOLOGY].