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Gapeam Budibac

Generic name: amantadine hcl, baclofen, bupivacaine hcl, cyclobenzaprine hcl, diclofenac sodium, gabapentin, and pentoxifylline
Dosage form: compounding kit

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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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

API LABELS

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

Gapeam Budibac
amantadine hcl, baclofen, bupivacaine hcl, cyclobenzaprine hcl, diclofenac sodium, gabapentin, and pentoxifylline kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:15455-0717
Packaging
# Item Code Package Description
1 NDC:15455-0717-1 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMANTADINE HYDROCHLORIDE (AMANTADINE) AMANTADINE HYDROCHLORIDE 1 g in 1 g
Packaging
# Item Code Package Description
1 13.2 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Part 2 of 8
BACLOFEN
baclofen powder, for suspension
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 1 g in 1 g
Packaging
# Item Code Package Description
1 3.25 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Part 3 of 8
BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride powder, for suspension
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE ANHYDROUS (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 1 g in 1 g
Packaging
# Item Code Package Description
1 8.25 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Part 4 of 8
CYCLOBENZAPRINE HYDROCHLORIDE
cyclobenzaprine hydrochloride powder, for suspension
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) CYCLOBENZAPRINE HYDROCHLORIDE 1 g in 1 g
Packaging
# Item Code Package Description
1 3.25 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Part 5 of 8
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 1 g in 1 g
Packaging
# Item Code Package Description
1 4.9 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Part 6 of 8
GABAPENTIN
gabapentin powder, for suspension
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 1 g in 1 g
Packaging
# Item Code Package Description
1 16.5 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Part 7 of 8
PENTOXIFYLLINE
pentoxifylline powder, for suspension
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENTOXIFYLLINE (PENTOXIFYLLINE) PENTOXIFYLLINE 1 g in 1 g
Packaging
# Item Code Package Description
1 16.5 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Part 8 of 8
CREAM BASE
cream base suspension
Product Information
Route of Administration TOPICAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
CETOSTEARYL ALCOHOL
POLYSORBATE 60
PEG-150 STEARATE
STEARETH-20
CYCLOMETHICONE 5
ETHYLHEXYL STEARATE
SORBITOL
ALOE VERA LEAF
ALPHA-TOCOPHEROL ACETATE
EDETATE DISODIUM
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 99.15 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/05/2014
Labeler - Alvix Laboratories, LLC (962445925)
Establishment
Name Address ID/FEI Operations
Alvix Laboratories, LLC 962445925 pack(15455-0717)
Alvix Laboratories, LLC