Label: ACYCLOVIR ointment

  • NDC Code(s): 33342-439-15, 33342-439-30
  • Packager: Macleods Pharmaceuticals Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 24, 2021

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  • DESCRIPTION
    Acyclovir USP is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP, 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP, 5 ...
  • CLINICAL PHARMACOLOGY
    Two clinical pharmacology studies were performed with acyclovir ointment 5% in immunocompromised adults at risk of developing mucocutaneous HSV infections or with localized varicella-zoster ...
  • INDICATIONS & USAGE
    Acyclovir Ointment 5% is indicated in the management of initial genital herpes and in limited non-life threatening mucocutaneous HSV infections in immunocompromised patients.
  • CONTRAINDICATIONS
    Acyclovir Ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.
  • WARNINGS
    Acyclovir Ointment 5% is intended for cutaneous use only and should not be used in the eye.
  • PRECAUTIONS
    General: The recommended dosage, frequency of applications, and length of treatment should not be exceeded (see DOSAGE AND ADMINISTRATION). There are no data to support the use of acyclovir ...
  • 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 ...
  • OVERDOSAGE
    Overdosage by topical application of acyclovir ointment 5% is unlikely because of limited transcutaneous absorption (see CLINICAL PHARMACOLOGY).
  • DOSAGE AND 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 ...
  • HOW SUPPLIED
    Each gram of acyclovir ointment USP, 5% contains 50 mg acyclovir, USP in a polyethylene glycol base. It is supplied as follows: 15 g tubes                   NDC 33342-439-15 - 30 g ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Acyclovir Topical Ointment USP, 5% Pack Type: 30 gms Tube label - NDC: 33342-439-30 - Acyclovir Topical Ointment USP, 5% Pack Type: 30 gms Carton label - NDC: 33342-439-30 - Acyclovir Topical ...
  • INGREDIENTS AND APPEARANCE
    Product Information