DIPENTOCAINE TOPICAL CREAM COMPOUNDING KIT- diclofenac sodium, gabapentin, and lidocaine hydrochloride 
Alvix Laboratories, LLC

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.

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Dipentocaine ™ Topical Cream Compounding Kit
For Pharmacy Prescription Compounding Only / Rx Only
For Topical Use Only

DESCRIPTION

Diclofenac 5%, Gabapentin 5%, Lidocaine HCl 2%

For Pharmacy Prescription Compounding Only / Rx Only

For Topical Use Only

Each Dipentocaine™ Topical Cream Pharmacy Compounding Kit provides 5.7 grams of Diclofenac Sodium USP, 5.7 grams of Gabapentin USP, 2.28 grams of Lidocaine HCL USP, and 100.32 grams of Base.

Diclofenac Sodium:

CAS Number 15307-79-6

2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt

Diclofenac Structure

Gabapentin:

CAS Number 60142-96-3

1-(Aminomethyl)-cyclohexaneacetic acid, Neurontin

gabapentin structure

Licocaine Hydrochloride Anhydrous:

CAS Number 6108-05-0
2-Diethylamino-N-(2,6-dimethylphenyl)acetamide hydrochloride monohydrate, Lignocaine hydrochloride monohydrate, Xylocaine hydrochloride monohydrate

lidocaine structure

WARNING

Diclofenac jSodium:

Pictogram

skull and cross bones pictogramHealth Hazard Pictogramexclamation point pictogram

Signal word: Danger

Hazard statement(s):

H301 Toxic if swallowed.

Precautionary statement(s):

P264 Wash skin thoroughly after handling.

P270 Do not eat, drink or smoke when using this product.

P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/ physician.

P321 Specific treatment (see supplemental first aid instructions on this label).

P330 Rinse mouth. P405 Store locked up.

P501 Dispose of contents/ container to an approved waste disposal plant.

Gabapentin:

Pictograms:

health hazard pictogrampictogram

Signal word: Danger

Hazard statement(s):

H315 Causes skin irritation.

H319 Causes serious eye irritation.

H335 May cause respiratory irritation.

H360 May damage fertility or the unborn child.

Precautionary statement(s):

P201 Obtain special instructions before use.

P202 Do not handle until all safety precautions have been read and understood.

P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.

P264 Wash skin thoroughly after handling.

P271 Use only outdoors or in a well-ventilated area.

P280 Wear protective gloves/ eye protection/ face protection.

P302 + P352 IF ON SKIN: Wash with plenty of soap and water.

P304 + P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.

P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P308 + P313 IF exposed or concerned: Get medical advice/ attention.

P321 Specific treatment (see supplemental first aid instructions on this label).

P332 + P313 If skin irritation occurs: Get medical advice/ attention.

P337 + P313 If eye irritation persists: Get medical advice/ attention.

P362 Take off contaminated clothing and wash before reuse.

P403 + P233 Store in a well-ventilated place. Keep container tightly closed. P405 Store locked up. P501 Dispose of contents/ container to an approved waste disposal plant.

Lidocaine Hydrochloride Anhydrous:

Pictogram

pictogram

Signal word: Danger

Hazard statement(s):

H301 Toxic if swallowed.

Precautionary statement(s):

P264 Wash skin thoroughly after handling.

P270 Do not eat, drink or smoke when using this product.

P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/ physician.

P321 Specific treatment (see supplemental first aid instructions on this label). P330 Rinse mouth.

P405 Store locked up.

P501 Dispose of contents/ container to an approved waste disposal plant.

HOW SUPPLIED

Kit Components: 5.7 g of Diclofenac Sodium, 5.7 g of Gabapentin, 2.28 g of Lidocaine Hydrochloride Anhydrous, and 100.32 g TDC Max Cream Base.

Equipment needed: mill, spatula, mixing bowl, and Topi-Pump™.

SIZE114 grams
NDC #15455-7566-1
Dichlofenac Sodium, USP5.7 grams
Gabapentin, USP5.7 grams
Lidocaine HCL, USP2.28 grams
Base100.32 grams

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.

The FDA has not approved Alvix-Dipentocaine™ Topical Cream Compounding Kit to cure, treat, or mitigate disease. Alvix-Dipentocaine™ Topical Cream intended for preparation in accordance with state and federal regulation governing compounding and is available to patients by prescription only.

Certificate of analysis on file

Rx ONLY

Marketed by:

Alvix Laboratories, LLC

1(888) 526-5449

Ocean Springs, MS 39564

Alvix Logo

STORAGE AND HANDLING

Prior to compounding, store Alvix- Dipentocaine™ Topical Cream Compounding Kit at room temperature between 20 - 25 degrees C (68 - 77 degrees F). Protect from light.

INSTRUCTIONS FOR USE

insert page 1insert page 2

CONTAINER LABELS

diclofenac labelgabapentin labellidocaine labelcream label

PRINCIPAL DISPLAY PANEL

NDC 15455-7566-1

Dipentocaine ™ Topical Cream

Diclofenac Sodium, Gabapentin, and Lidocaine Hydrochloride Compounding Kit

FOR PHARMACY PRESCRIPTION COMPOUNDING ONLY / Rx Only

Carton label

DIPENTOCAINE TOPICAL CREAM COMPOUNDING KIT 
diclofenac sodium, gabapentin, and lidocaine hydrochloride kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:15455-7566
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15455-7566-11 in 1 CARTON11/06/201403/08/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CONTAINER 5.7 g
Part 21 CONTAINER 5.7 g
Part 31 CONTAINER 2.28 g
Part 41 CONTAINER 100.32 g
Part 1 of 4
DICLOFENAC SODIUM 
diclofenac sodium powder, for suspension
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM5.7 g  in 5.7 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15.7 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
Part 2 of 4
GABAPENTIN 
gabapentin powder, for suspension
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN5.7 g  in 5.7 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15.7 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
Part 3 of 4
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride powder, for suspension
Product Information
Route of AdministrationTOPICAL
Inactive Ingredients
Ingredient NameStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) 2.25 g  in 2.25 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12.28 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
Part 4 of 4
TDC MAX CREAM BASE 
cream base suspension
Product Information
Route of AdministrationTOPICAL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG-150 STEARATE (UNII: 7BSG7DF10Q)  
STEARETH-20 (UNII: L0Q8IK9E08)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
SORBITOL (UNII: 506T60A25R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1100.32 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/06/201403/08/2018
Labeler - Alvix Laboratories, LLC (962445925)

Revised: 3/2018
 
Alvix Laboratories, LLC