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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DESCRIPTIONAcyclovir 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 ...
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CLINICAL PHARMACOLOGYTwo clinical pharmacology studies were performed with acyclovir ointment 5% in immunocompromised adults at risk of developing mucocutaneous HSV infections or with localized varicella-zoster ...
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INDICATIONS & USAGEAcyclovir Ointment 5% is indicated in the management of initial genital herpes and in limited non-life threatening mucocutaneous HSV infections in immunocompromised patients.
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CONTRAINDICATIONSAcyclovir Ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.
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WARNINGSAcyclovir Ointment 5% is intended for cutaneous use only and should not be used in the eye.
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PRECAUTIONSGeneral: 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 ...
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ADVERSE REACTIONSIn 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 ...
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OVERDOSAGEOverdosage by topical application of acyclovir ointment 5% is unlikely because of limited transcutaneous absorption (see CLINICAL PHARMACOLOGY).
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DOSAGE AND ADMINISTRATIONApply 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 ...
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HOW SUPPLIEDEach 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 ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELAcyclovir 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 ...
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INGREDIENTS AND APPEARANCEProduct Information