Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Acyclovir Ointment USP, 5% is supplied as a white to off-white color ointment. Each gram of acyclovir ointment USP, 5% contains 50 mg acyclovir, USP in a polyethylene glycol base. It is supplied as follows: 5-g tubes NDC 62332-248-05 15-g tubes NDC 62332-248-15 30-g tubes NDC 62332-248-30 Store at 15° to 25°C (59° to 77°F). [See USP Controlled Room Temperature]. Store in a dry place Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information call Alembic Pharmaceuticals Limited at 1-866-210-9797. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Manufactured by: Encube Ethicals Pvt. Ltd., Madkaim, Ponda, Goa, India – 403404 Mfg. License No: 361 Revised: 03/2025; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 5g Rx only NDC 62332-248-05 5 g Acyclovir Ointment USP, 5%( g in 1 tube) Each gram contains acyclovir, USP 50 mg in a polyethylene glycol base. acyclovir-05gt.jpg; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 15g Rx only NDC 62332-248-15 15 g Acyclovir Ointment USP, 5%(15 g in 1 tube) Each gram contains acyclovir, USP 50 mg in a polyethylene glycol base acyclovir-15gt.jpg; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30g Rx only NDC 62332-248-30 30 g Acyclovir Ointment USP, 5%(30 g in 1 tube) Each gram contains acyclovir, USP 50 mg in a polyethylene glycol base acyclovir-30gt.jpg
- HOW SUPPLIED Acyclovir Ointment USP, 5% is supplied as a white to off-white color ointment. Each gram of acyclovir ointment USP, 5% contains 50 mg acyclovir, USP in a polyethylene glycol base. It is supplied as follows: 5-g tubes NDC 62332-248-05 15-g tubes NDC 62332-248-15 30-g tubes NDC 62332-248-30 Store at 15° to 25°C (59° to 77°F). [See USP Controlled Room Temperature]. Store in a dry place Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information call Alembic Pharmaceuticals Limited at 1-866-210-9797. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Manufactured by: Encube Ethicals Pvt. Ltd., Madkaim, Ponda, Goa, India – 403404 Mfg. License No: 361 Revised: 03/2025
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 5g Rx only NDC 62332-248-05 5 g Acyclovir Ointment USP, 5%( g in 1 tube) Each gram contains acyclovir, USP 50 mg in a polyethylene glycol base. acyclovir-05gt.jpg
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 15g Rx only NDC 62332-248-15 15 g Acyclovir Ointment USP, 5%(15 g in 1 tube) Each gram contains acyclovir, USP 50 mg in a polyethylene glycol base acyclovir-15gt.jpg
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30g Rx only NDC 62332-248-30 30 g Acyclovir Ointment USP, 5%(30 g in 1 tube) Each gram contains acyclovir, USP 50 mg in a polyethylene glycol base acyclovir-30gt.jpg
Overview
Acyclovir, USP, is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment USP, 5% is a formulation for topical administration. Each gram acyclovir ointment USP, 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir, USP 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. 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: Structure
Indications & Usage
Acyclovir ointment USP, 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.
Dosage & Administration
Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The dose size per application will vary depending upon the total lesion area but should approximate a one-half inch ribbon of ointment per 4 square inches of surface area. A finger cot or rubber glove should be used when applying acyclovir ointment 5% to prevent autoinoculation of other body sites and transmission of infection to other persons. Therapy should be initiated as early as possible following onset of signs and symptoms.
Warnings & Precautions
WARNINGS Acyclovir ointment 5% is intended for cutaneous use only and should not be used in the eye.
Contraindications
Acyclovir ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.
Adverse Reactions
In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. Local pruritus occurred in 4% of these patients. In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings. Observed During Clinical Practice: Based on clinical practice experience in patients treated with acyclovir ointment 5% in the US, spontaneously reported adverse events are uncommon. Data are insufficient to support an estimate of their incidence or to establish causation. These events may also occur as part of the underlying disease process. Voluntary reports of adverse events that have been received since market introduction include: General: Edema and/or pain at the application site. Skin: Pruritus, rash.
Drug Interactions
Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with acyclovir ointment 5%.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.