Acyclovir
Tablet · Oral, Topical, Intravenous
Uses
Acyclovir Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. Acyclovir Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. ( 1 )
Dosage and administration
Acyclovir Cream should be applied 5 times per day for 4 days. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis, i.e. during the prodrome or when lesions appear. For adolescents 12 years of age and older, the dosage is the same as in adults. Apply 5 times a day for 4 days. ( 2 ) Administer immediately following the onset of cold sore lesions. ( 2 )
Dosage forms and strengths
Each gram of Acyclovir Cream contains 50 mg (equivalent to 5% w/w) of acyclovir. Cream, 50 mg (equivalent to 5% w/w) acyclovir. ( 3 )
Contraindications
Acyclovir Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation. Acyclovir Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir or any component of the formulation. ( 4 )
Warnings and precautions
Only for topical use of recurrent HSV lesions on the external aspect of lips and the face. Acyclovir Cream should not be applied on mucous membranes including in the eye or inside the mouth or nose. ( 5.1 ) There is a potential for irritation and contact sensitization. ( 5.2 ) 5.1 General Acyclovir 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. Acyclovir Cream is intended for cutaneous use only and should not be used in the eye or inside the mouth or nose. 5.2 Contact Sensitization Acyclovir Cream has a potential for irritation and contact sensitization [see Adverse Reactions (6.1) ] . The effect of Acyclovir Cream has not been established in immunocompromised patients.
Side effects
The most common adverse reactions reported were local skin reactions at the application site. ( 6.1 ) Angioedema, anaphylaxis, contact dermatitis and eczema have been reported. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in clinical practice. In five double-blind, placebo-controlled trials, 1124 patients were treated with Acyclovir Cream and 1161 with placebo (vehicle) cream. Local application site reactions were reported by 5% of patients receiving Acyclovir Cream and 4% of patients receiving placebo. The most common adverse reactions at the site of topical application were dry lips, desquamation, dryness of skin, cracked lips, burning skin, pruritus, flakiness of skin, and stinging on skin; each adverse reaction occurred in less than 1% of patients receiving Acyclovir Cream and placebo. Three patients on Acyclovir Cream and one patient on placebo discontinued treatment due to an adverse event. An additional study, enrolling 22 healthy adults, was conducted to evaluate the dermal tolerance of Acyclovir Cream compared with vehicle using single occluded and semi-occluded patch testing methodology. Both Acyclovir Cream and placebo showed a high and cumulative irritation potential. Another study, enrolling 251 healthy adults, was conducted to evaluate the contact sensitization potential of Acyclovir Cream using repeat insult patch testing methodology. Of 202 evaluable subjects, possible cutaneous sensitization reactions were observed in the same 4 (2%) subjects with both Acyclovir Cream and placebo, and these reactions to both Acyclovir Cream and placebo were confirmed in 3 subjects upon rechallenge. The sensitizing ingredient(s) has not been identified. The safety profile in patients 12 to 17 years of age was similar to that observed in adults. 6.2 Postmarketing Experience In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of acyclovir cream. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to acyclovir cream. General: Angioedema, anaphylaxis. Skin: Contact dermatitis, eczema.
Drug interactions
Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir Cream. Due to minimal systemic absorption of Acyclovir Cream, systemic drug interactions are unlikely. Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir Cream. Due to minimal systemic absorption of Acyclovir Cream, systemic drug interactions are unlikely. ( 7 )
Use in specific populations
8.1 Pregnancy Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the Acyclovir Cream [see Clinical Pharmacology (12.3) ] . Experience with topical acyclovir use in pregnant women over several decades, based on published literature including observational studies, has not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies with systemic exposure of acyclovir have been conducted. Refer to acyclovir prescribing information for additional details. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and breastfeeding is not expected to result in exposure of the child to Acyclovir Cream [see Clinical Pharmacology (12.3) ] . There are no data on the effects of Acyclovir on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Acyclovir Cream and any potential adverse effects on the breastfed child from Acyclovir Cream or from the underlying maternal condition. 8.4 Pediatric Use An open-label, uncontrolled trial with Acyclovir Cream 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. 8.5 Geriatric Use 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 (12.3) ] .
Pregnancy
8.1 Pregnancy Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the Acyclovir Cream [see Clinical Pharmacology (12.3) ] . Experience with topical acyclovir use in pregnant women over several decades, based on published literature including observational studies, has not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies with systemic exposure of acyclovir have been conducted. Refer to acyclovir prescribing information for additional details. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Pediatric use
8.4 Pediatric Use An open-label, uncontrolled trial with Acyclovir Cream 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.
Geriatric use
8.5 Geriatric Use 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 (12.3) ] .
Overdosage
Overdosage by topical application of Acyclovir Cream is unlikely because of minimal systemic exposure [see Clinical Pharmacology (12.3) ] . There is no information available for overdose.
Description
Acyclovir is a synthetic deoxynucleoside analogue active against herpes viruses. Acyclovir Cream 5% is a formulation for topical administration. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy) methyl]-6 H -purin-6-one; it has the following structural formula: Acyclovir is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. Each gram of Acyclovir Cream contains 50 mg (equivalent to 5% w/w) of acyclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water and white petrolatum. chemstructure
Mechanism of action
12.1 Mechanism of Action Acyclovir is an antiviral drug active against α-herpesviruses [see Microbiology (12.4) ] .
How supplied
Each gram of Acyclovir Cream contains 50 mg (equivalent to 5% w/w) of acyclovir in an aqueous cream base. Acyclovir Cream is supplied as follows: 5 g tubes NDC 0093-3630-20 Store at or below 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Storage
Store at or below 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). General Patients should be informed that Acyclovir Cream is a prescription topical cream for the treatment of cold sores (recurrent herpes labialis) that occur on the face and lips. Acyclovir Cream is not a cure for cold sores. Patients should be instructed that Acyclovir Cream is intended for cutaneous use only for herpes labialis of the lips and around the mouth. Patients should be advised that Acyclovir 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 Acyclovir Cream. Do not use if you are allergic to Acyclovir Cream or any of the ingredients in Acyclovir Cream. Before you use Acyclovir 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. Instruct patients to wash hands prior to application and ensure the face and/or lips are clean and dry. Advise patients to apply Acyclovir Cream topically 5 times per day for 4 days. Instruct patients to topically apply a quantity of Acyclovir Cream sufficient to cover the affected area, including the outer margin. Advise patients to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Instruct patients to wash their hands with soap and water after using Acyclovir Cream. Keep out of reach of children. Possible Side Effects Common skin-related side effects that occurred when Acyclovir Cream was applied include application site reactions. Acyclovir Cream has the potential for irritation and contact sensitization. Manufactured in Canada by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Revised February 2021 9673501
Label text from the FDA structured product label by Teva Pharmaceuticals USA, Inc. (revised Oct 23, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acyclovir in 183 products
- Acyclovir Sodium in 10 products
Acyclovir NDC products (193)
Acyclovir recalls
- D-0367-2021 May 12, 2021 · Class III · Terminated
Labeling: Incorrect or Missing Lot and/or Exp Date - D-0315-2021 Apr 7, 2021 · Class I · Terminated
Crystallization: customer complaints for crystallization in finished product. - D-0316-2021 Apr 7, 2021 · Class I · Terminated
Crystallization: customer complaints for crystallization in finished product. - D-1272-2019 May 15, 2019 · Class II · Terminated
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg - D-0544-2018 Mar 7, 2018 · Class II · Terminated
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities. - D-0897-2017 Jun 14, 2017 · Class III · Terminated
Presence of Foreign Substance: human hair melded into tablet. - D-017-2014 Dec 4, 2013 · Class II · Terminated
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Frequently asked questions
What is Acyclovir used for?
Acyclovir Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. Acyclovir Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold…
What are the side effects of Acyclovir?
The most common adverse reactions reported were local skin reactions at the application site. ( 6.1 ) Angioedema, anaphylaxis, contact dermatitis and eczema have been reported. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under… See the full label for the complete list.
Who makes Acyclovir?
Acyclovir is listed by 64 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., Advagen Pharma Limited, Advanced Rx Pharmacy of Tennessee, LLC.
Has Acyclovir been recalled?
The FDA enforcement database lists 7 recalls for Acyclovir, most recently D-0367-2021 (class iii): Labeling: Incorrect or Missing Lot and/or Exp Date