Preparation Instructions
Lidocaine HCL 2%, Ketoprofen 10%
FOR PRESCRIPTION COMPOUNDING ONLY
DESCRIPTION
Each Vopac Cream Compounding Pac provides 2.48 grams of micronized Lidocaine HCL USP, 11.050 grams of Ketoprofen USP, 12.47 ml of Lecithin Organogel USP and 88 grams of base cream. The resulting mixture is intended for topical use.
COMPOUNDING DIRECTIONS
TO THE PHARMACIST
Pack Components: 1 color coded red label bottle of 2.48 g of Lidocaine Hcl, 2 color coded yellow label bottles of 5.525 g of Ketoprofen, 1 tube of 88 g Base, 1 mixing jar of pre-weighed Lecithin Organogel, and 1 sterile stirring stick.
| Base Cream | 88.0 grams |
| Ketoprofen, USP | 11.05 grams |
| Lidocaine HCL, USP | 2.48 grams |
| Lecithin Organogel | 12.47 ml |
| SIZE | 114 grams |
Prior to compounding, store Vopac Cream Compounding Preparation Pack at room temperature between 20-25 degrees C (68-77 degrees F).
Based on real time controlled room temperature and humidity testing, Vopac Cream finished compounding preparation product is stable for at least 30 days1
Vopac Cream Compounding Preparation meets the requirements for total aerobic microbial count of not more than 100 cfu/mL, as well as for the absence of the specified microorganisms Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Salmonella spp. when tested as described in the current USP under <61> Microbial Enumeration Tests and <62> Tests for Specified Microorganisms. Vopac Cream Compounding Preparation suspension also meets the requirements as described in the current USP under <51> Antimicrobial Effectiveness Testing for Category 2 products.
For external use only: Avoid contact with eyes. Keep container tightly closed. Keep out of the reach of children. Compounded product, as dispensed, is stable for at least 30 days *Certificate of analysis on file
Compounding Directions
Important Prior to dispensing: Mixing Jar includes Lecithin liquid inside. DO NOT SPILL
Lecithin liquid is inside the mixing jar.
DO NOT SPILL when opening.
- 1.
- Open "Mixing Jar" (mixing jar has Lecithin liquid inside). Be careful not to spill the contents while mixing.
- 2.
- Tap the top and bottom of the "Lidocaine HCL" bottle. Open the bottle and empty the Lidocaine HCL into the Lecithin mixing jar and mix.
- 3.
- Tap the top and bottom of the "Ketoprofen" bottles. Open both bottles (2 bottles) and empty the Ketoprofen into the Lecithin mixing jar.
- 4.
- Stir gently with the enclosed stirrer provided for approximately 20 – 30 seconds until powders are wet and paste like in appearance. The appropriate quantities of powders 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.
- 5.
- Gradually add the tube of "Base Cream" to the mixing jar while stirring. Mix until homogeneous in appearance.
- 6.
- Add prescription label to the mixing jar and provide to patient.
Recommended Administration and Dosage
Apply thin layer (approximately 1/4 tsp) of mixed cream over specific site area every 4-6 hours or as needed.
Patent Pending
NDC #51021-880-14
Rx ONLY
Manufactured for & Marketed by: Sircle Laboratories, LLC, Madison, MS 39110
VOPAC TOPICAL CREAM COMPOUNDING PAC – lidocaine hydrochloride, ketoprofen
PRINCIPAL DISPLAY PANEL - Kit Carton Label
Keep This End Upright
Compounding Pack for Prescription Compounding Only
**Pharmacist/Physician** **Mixing Instructions Inside**
NDC 51021-880- 14
Rx Only
Components:
2 bottles of 5.525g Ketoprofen
1 bottle of 2.48g Lidocaine HCL
1 tube of Base Cream
1 stirring stick
1 mixing jar with Lecithin inside
1 mixing instructions
VOPAC™
Ketoprofen 10% / Lidocaine HCL 2%
Topical Cream Compounding Pac
