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Zyvodol

Generic Name: diclofenac sodium, amitriptyline hydrochloride, prilocaine hydrochloride and lidocaine
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Zyvodol® Cream
(Diclofenac Sodium USP, Amitriptyline HCl USP, Prilocaine HCl USP, Lidocaine HCl USP)

Topical Cream (as dispensed): Diclofenac Sodium 3%, Amitriptyline 4%, Prilocaine 2.5%, Lidocaine 2.5%
For Topical Use Only – Not for Ophthalmic Use or Oral Use

* MUST RECONSTITUTE BEFORE DISPENSING *

Rx Only
69167-0815-09

Zyvodol Description

Zyvodol® is comprised of 3 g of Diclofenac Sodium USP, 4 g of Amitriptyline HCl USP, 2.5 g of Prilocaine HCl USP, and 2.5 g of Lidocaine HCl USP for topical use.1 Zyvodol® also contains a Cream Base containing purified water, white petrolatum, sorbitol solution, cetearyl alcohol, propylene glycol, ceteareth-20, simethicone, glyceryl monostearate, polyethylene glycol monostearate, sorbic acid and BHT. When mixed as instructed, the final product provides a homogeneous cream mixture containing Diclofenac Sodium, Amitriptyline HCl, Prilocaine HCl, and Lidocaine HCl comparable to the active ingredients (Voltaren Gel® 1%, Elavil®, and Emla® 2.5%/2.5%) contained in Zyvodol®, as dispensed. 2

1
Certificate of analysis on file
2
This product is not manufactured by Novartis, manufacturer of Voltaren Gel®, AstraZeneca Pharmaceuticals, manufacturer of Elavil® and Emla®.

Zyvodol Dosage and Administration

The pharmacist must mix contents of each container with appropriate amount of Cream Base yielding a final volume of 100 grams at the time of dispensing. Pharmacist may utilize diluent(s) if needed from the respective active component Material Safety Data Sheet only. For topical use only. This product should not be administered orally.

Contraindications

Zyvodol® Topical Cream, as dispensed, is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

USES

Consult your pharmacist.

HOW TO USE

Consult your pharmacist.

Precautions

Consult your pharmacist.

Drug Interactions

Consult your pharmacist. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

SIDE EFFECTS

Consult your pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

MISSED DOSE

Consult your pharmacist.

NOTES

No Monograph available at this time.

How is Zyvodol Supplied

Zyvodol® Cream, as dispensed, is supplied as six component package: four containers which contain the active components Diclofenac Sodium USP 3 g, Amitriptyline HCl USP 4 g, Prilocaine HCl USP 2.5 g, Lidocaine HCl USP 2.5 g (respectively), a separate package of Cream Base and a stirring apparatus. The pharmacist must mix contents of each active component container with appropriate amount of Cream Base such that the QS volume yields 100 grams (final weight) at the time of dispensing. Pharmacist may utilize appropriate diluents if needed from the respective active component Material Safety Data Sheet only. Pharmacist must only use appropriate amount of Cream Base such that the final volume yields 100 grams inclusive of all drug substances, any diluents that may have been added, and Cream Base. Pharmacist may dispense final product upon reconstituting and mixing into a dispensing container of their choice or as directed by prescriber.

Mix for 12 minutes before dispensing. May use mixing aid.

Shake well before using.

Store between 15° and 30°C (59° and 86°F) in tightly closed containers prior to mixing. Store final product at refrigerated temperature, 2°-8°C (36°-46°F).

For topical use only. Avoid contact with eyes. Keep container tightly closed. Keep out of the reach of children. Protect from light. Protect from freezing. Zyvodol® Cream, as dispensed, is stable for at least 30 days at refrigerated temperature as recommended under USP 795 Guidelines.


U.S. Patent Pending

Distributed By: Accumix Pharmaceuticals
                        East Windsor, NJ 08520


Issued: October 2014 v1

Rx ONLY
For External Use Only

PRINCIPAL DISPLAY PANEL - NDC: 69167-0815-9 - Carton Label

Zyvodol 
diclofenac sodium, amitriptyline hydrochloride, prilocaine hydrochloride and lidocaine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69167-0815
Packaging
# Item Code Package Description
1 NDC:69167-0815-9 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 PACKAGE 3 g
Part 2 1 PACKAGE 4 g
Part 3 1 PACKAGE 2.5 g
Part 4 1 PACKAGE 2.5 g
Part 5 1 BOTTLE 113 g
Part 1 of 5
DICLOFENAC SODIUM 
diclofenac sodium powder, for suspension
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 3 g  in 3 g
Packaging
# Item Code Package Description
1 3 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/15/2014
Part 2 of 5
AMITRIPTYLINE HYDROCHLORIDE 
amitriptyline hydrochloride powder, for suspension
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 4 g  in 4 g
Packaging
# Item Code Package Description
1 4 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/15/2014
Part 3 of 5
PRILOCAINE HYDROCHLORIDE 
prilocaine hydrochloride powder, for suspension
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRILOCAINE HYDROCHLORIDE (PRILOCAINE) PRILOCAINE HYDROCHLORIDE 2.5 g  in 2.5 g
Packaging
# Item Code Package Description
1 2.5 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/15/2014
Part 4 of 5
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride powder, for suspension
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2.5 g  in 2.5 g
Packaging
# Item Code Package Description
1 2.5 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/15/2014
Part 5 of 5
CREAM BASE 
cream cream
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
WATER  
PETROLATUM  
SORBITOL  
CETOSTEARYL ALCOHOL  
PROPYLENE GLYCOL  
POLYOXYL 20 CETOSTEARYL ETHER  
DIMETHICONE  
GLYCERYL MONOSTEARATE  
POLYETHYLENE GLYCOLS  
SORBIC ACID  
BUTYLATED HYDROXYTOLUENE  
Packaging
# Item Code Package Description
1 113 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/15/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/15/2014
Labeler - Accumix Pharmaceuticals (079460461)
Revised: 01/2015
 
Accumix Pharmaceuticals



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