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 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 USP 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

Each gram of Acyclovir ointment USP 5% contains 50 mg acyclovir in a polyethylene glycol base. It is supplied as follows:

15-gm tubes (NDC 69097-656-38)

30-gm tubes (NDC 69097-656-40).

Store at 15° to 25°C (59° to 77°F) in a dry place.

Manufactured by:

Cipla Ltd.

Verna Goa, India

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

Issued: 3/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69097- 656 -38 Rx Only

15 g

Acyclovir Ointment, USP

5%

Each gram contains acyclovir, USP 50 mg in a polyethylene glycol base

FOR CUTANEOUS USE ONLY

Cipla

NDC 69097- 656 -38 Rx Only

Acyclovir Ointment, USP

5%

Each gram contains acyclovir, USP 50 mg in a polyethylene glycol base

FOR CUTANEOUS USE ONLY

Cipla 15 g

ACYCLOVIR acyclovir ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-656 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 GLYCOL, UNSPECIFIED

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69097-656-40 1 TUBE in 1 CARTON contains a TUBE 1 30 g in 1 TUBE This package is contained within the CARTON (69097-656-40) 2 NDC:69097-656-38 1 TUBE in 1 CARTON contains a TUBE 2 15 g in 1 TUBE This package is contained within the CARTON (69097-656-38)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211794 01/18/2019

Labeler — Cipla USA Inc. (078719707)

Registrant — Cipla USA Inc. (078719707)

Establishment
Name	Address	ID/FEI	Operations
Cipla Ltd.- Goa		650072015	MANUFACTURE (69097-656)

Revised: 03/2021 Cipla USA Inc.