GAPEAM BUDIBAC- amantadine hcl, baclofen, bupivacaine hcl, cyclobenzaprine hcl, diclofenac sodium, gabapentin, and pentoxifylline
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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Alvix-Gapeam Budibac Compounding Ingredients
For Pharmacy Prescription Compounding Only / Rx Only
For Topical Use Only

FOR PRESCRIPTION COMPOUNDING ONLY

DESCRIPTION

Gabapentin, Pentoxifylline, AmantadineHCL, Bupivacaine HCL, Diclofenac Sodium, Baclofen, Cyclobenzaprine HCL.

Each Alvix- Gapeam Budibac Compounding Ingredients provides 16.5 grams of Gabapentin USP, 16.5 grams of Pentoxifylline USP, 13.2 grams of Amantadine HCL USP, 8.25 grams of Bupivacaine HCL USP, 4.9 grams of Diclofenac Sodium USP, 3.25 grams of Baclofen USP, 3.25 grams of Cyclobenzaprine HCL USP for incorporation into 99.15 grams of TDC Max Cream Base.

STORAGE AND HANDLING

Prior to compounding, store Alvix- Gapeam Budibac Compounding Ingredients at room temperature between 15 - 30 degrees C (59 - 86 degrees F).
For non-sterile 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.

PACKAGE INSERT

Insert Page 1 Insert Page 2

API LABELS

Gabapentin Label Pentoxifyline Label Amantadine label Bupivacaine Label Diclofenac Label Baclogen Label Cyclobenzaprine Label TDC Max Cream Label

PRINCIPAL DISPLAY PANEL

NDC 15455-0717-1 RX ONLY

Alvix-Gapeam Budibac™

Amantadine HCl, Baclofen, Bupivacaine HCl, Cyclobenzaprine HCl, Diclofenac Sodium, Gabapentin, and Pentoxifylline Compounding Ingredients

FOR PRESCRIPTION COMPOUNDING ONLY

165 grams as dispensed

Carton Label

GAPEAM BUDIBAC
amantadine hcl, baclofen, bupivacaine hcl, cyclobenzaprine hcl, diclofenac sodium, gabapentin, and pentoxifylline kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:15455-0717

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15455-0717-1	1 in 1 CARTON	01/20/2015	03/08/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 CONTAINER	13.2 g
Part 2	1 CONTAINER	3.25 g
Part 3	1 CONTAINER	8.25 g
Part 4	1 CONTAINER	3.25 g
Part 5	1 CONTAINER	4.9 g
Part 6	1 CONTAINER	16.5 g
Part 7	1 CONTAINER	16.5 g
Part 8	1 CONTAINER	99.15 g

Part 1 of 8

AMANTADINE HYDROCHLORIDE
amantadine hydrochloride powder, for suspension

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMANTADINE HYDROCHLORIDE (UNII: M6Q1EO9TD0) (AMANTADINE - UNII:BF4C9Z1J53)	AMANTADINE HYDROCHLORIDE	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		13.2 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Part 2 of 8

BACLOFEN
baclofen powder, for suspension

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)	BACLOFEN	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		3.25 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Part 3 of 8

BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride powder, for suspension

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPIVACAINE HYDROCHLORIDE ANHYDROUS (UNII: AKA908P8J1) (BUPIVACAINE - UNII:Y8335394RO)	BUPIVACAINE HYDROCHLORIDE ANHYDROUS	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8.25 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Part 4 of 8

CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride powder, for suspension

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)	CYCLOBENZAPRINE HYDROCHLORIDE	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		3.25 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Part 5 of 8

DICLOFENAC SODIUM
diclofenac sodium powder, for suspension

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)	DICLOFENAC SODIUM	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.9 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Part 6 of 8

GABAPENTIN
gabapentin powder, for suspension

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		16.5 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Part 7 of 8

PENTOXIFYLLINE
pentoxifylline powder, for suspension

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PENTOXIFYLLINE (UNII: SD6QCT3TSU) (PENTOXIFYLLINE - UNII:SD6QCT3TSU)	PENTOXIFYLLINE	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		16.5 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Part 8 of 8

CREAM BASE
cream base suspension

Product Information
Route of Administration	TOPICAL

Ingredient Name	Strength
Inactive Ingredients
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		99.15 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/05/2014	03/08/2018

Labeler - Alvix Laboratories, LLC (962445925)

Name	Address	ID/FEI	Business Operations
Establishment
Alvix Laboratories, LLC		962445925	pack(15455-0717)

Revised: 3/2018

Document Id: 673dc8db-626f-c569-e053-2a91aa0ae7f6

Set id: 44c4d672-450a-434e-8b1f-6cc4b54916e3

Version: 3

Effective Time: 20180312