LIDOVIR- acyclovir and lidocaine hydrochloride   
Allegis Pharmaceuticals, LLC

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LidoVir Ointment Compounding Kit

Preparation Instructions

Acyclovir 4%, Lidocaine HCl 4% in White Petrolatum

FOR PRESCRIPTION COMPOUNDING ONLY

DESCRIPTION

Each LidoVir Ointment Compounding Kit provides 2.48 grams of micronized Lidocaine HCl, and 2.48 grams of micronized Acyclovir powder USP1 for incorporation into 57.2 grams of White Petrolatum. The resulting mixture is intended for topical use.


1
Certificate of analysis on file

Compounding Directions

TO THE PHARMACIST

Kit Components

1 color coded blue bottle of 2.48g Acyclovir, 1 color coded red bottle of 2.48g Lidocaine HCl, 2 color coded orange tubes of White Petrolatum, 1 stirring stick, 1 empty white mixing jar.

Color Coded Compounding
  1. Add the first tube of White Petrolatum to the Mixing Jar.
  2. Add the Acyclovir to the Mixing Jar. Tap all contents out of the vial.
  3. Add the Lidocaine HCl to the Mixing Jar. Tap all contents out of the vial.
  4. Add the second tube of White Petrolatum gradually while stirring.
  5. Stir gently with the enclosed stirrer for approximately 1-2 minutes until homogeneous in appearance. The appropriate quantities of acyclovir powder and lidocaine hydrochloride powder have been packaged in each bottle to deliver the required dosage of each drug. Residual quantities remaining in the bottles after emptying need not be rinsed out.

Prior to compounding, store LidoVir Ointment Compounding Kit at room temperature between 15 – 30 degrees C (59 – 86 degrees F).

LidoVir Ointment Compounding Kit components have a two-year expiration date.

For external use only. Avoid contact with eyes. Keep container tightly closed. Keep out of reach of children. Protect from light. Dispose of product after 30 days of being compounded.

How Supplied

Size62.2 grams
NDC#28595-973-62
Lidocaine HCl, USP2.48 grams
Acyclovir, USP2.48 grams
White Petrolatum57.2 grams

The FDA has not approved LidoVir Ointment to cure, treat, or mitigate disease. LidoVir Ointment is intended for preparation in accordance with state and federal regulation governing compounding and is available to patients by prescription only.

Rx ONLY

Marketed by: Sircle Laboratories, Jackson, MS 39046

LidoVirOintment
Acyclovir 4%/Lidocaine 4%
In White Petrolatum Compounding Kit

PRINCIPAL DISPLAY PANEL - 62.2 g Jar Carton

NDC 28595-973-62

Rx Only

LidoVir™ Ointment
Acyclovir 4%/Lidocaine HCl 4%
In White Petrolatum Compounding Kit

Acyclovir 4%
Lidocaine HCl 4%

Compounding Kit for Prescription Compounding Only

Each kit contains:

Acyclovir                2.48g

Lidocaine HCl        2.48g

White Petrolatum    57.2g

Topical
Ointment

62.2 g (as dispensed)

SIRCLE
Laboratories

PRINCIPAL DISPLAY PANEL - 62.2 g Jar Carton
LIDOVIR 
acyclovir and lidocaine hydrochloride kit
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:28595-973
Packaging
#Item CodePackage Description
1NDC:28595-973-6212 in 1 CASE
11 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 JAR 2.48 g
Part 21 JAR 2.48 g
Part 32 TUBE 57.2 g
Part 1 of 3
ACYCLOVIR 
acyclovir powder
Product Information
Item Code (Source)NDC:28595-592
Route of AdministrationNOT APPLICABLEDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acyclovir (Acyclovir) Acyclovir2.48 g  in 62.2 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:28595-592-772.48 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Bulk Ingredient For Human Prescription Compounding02/15/2012
Part 2 of 3
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride powder
Product Information
Item Code (Source)NDC:28595-610
Route of AdministrationNOT APPLICABLEDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride2.48 g  in 62.2 g
Packaging
#Item CodePackage Description
1NDC:28595-610-802.48 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Bulk Ingredient For Human Prescription Compounding02/15/2012
Part 3 of 3
PETROLATUM 
petrolatum jelly
Product Information
Item Code (Source)NDC:67777-211
Route of AdministrationNOT APPLICABLEDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Petrolatum (Petrolatum) Petrolatum1 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:67777-211-0328.6 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Bulk Ingredient For Human Prescription Compounding02/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Bulk Ingredient For Human Prescription Compounding02/15/2012
Labeler - Allegis Pharmaceuticals, LLC (792272861)

Revised: 04/2012
 
Allegis Pharmaceuticals, LLC