Acyclovir (Page 2 of 2)

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.

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 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.

HOW SUPPLIED

Acyclovir Ointment, USP 5% is supplied as a 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:

15-g tubes (NDC 65162-835-94)

30-g tubes (NDC 65162-835-96)

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a dry place.

Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807

Rev. 02-2016-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mg
(click image for full-size original)

Carton 15 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mg
(click image for full-size original)

Tube Label 15 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mg
(click image for full-size original)

Carton 30 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mg
(click image for full-size original)

Tube Label 30 g

ACYCLOVIR
acyclovir ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-835
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOLS
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-835-96 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (65162-835-96)
2 NDC:65162-835-94 1 TUBE in 1 CARTON contains a TUBE
2 15 g in 1 TUBE This package is contained within the CARTON (65162-835-94)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204605 01/03/2014
Labeler — Amneal Pharmaceuticals of New York, LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals, LLC 053542455 ANALYSIS (65162-835), LABEL (65162-835), MANUFACTURE (65162-835), PACK (65162-835)

Revised: 03/2016 Amneal Pharmaceuticals of New York, LLC

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