Instructions for PreparationPage 1Page 2
NDC 70332-101-01 For Prescription Compounding Only Rx only
RapidPaq™ Ketophene™
(20% Ketoprofen topical cream kit)
RapidPaq™ kits provide a convenient approach to rapidly prepare prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practices (cGMP).
Description:
This kit contains active and inactive materials to prepare approximately 167 grams of ketoprofen topical cream. This kit may only be used for prescription compounding by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient.
Active Ingredients:
- 33.5 g Ketoprofen, USP
Inactive Ingredients:
- 100 g RapidPaq Cream Base (D.I Water, Cetearyl Alcohol, Cyclomethicone, Polysorbate-60, Sorbitol, Phenoxyethanol(and)ethylhexlglycerin,
Tocopheryl Acetate, Aloe Barbadensis, Disodium EDTA,)
- 33.5 g ethoxy diglycol
- Spatula
-Instructions
Pharmacist instructions for Preparation
1 Remove and Inspect the Contents of the Kit
Ensure that all components are present. Ensure that the safety seals are present on the Ketoprofen, ethoxy diglycol and RapidPaq Cream Base. If components are missing or not intact, do not use the kit.
2 Prepare for Mixing
Wear gloves and eye protection during mixing operations. Remove cap and seal from the RapidPaq Cream Base. Break the seal and remove the cap from the Ketoprofen and ethoxy diglycol.
3 Dissole the Ketoprofen
Transfer approximately 2/3 of the ethoxy diglycol to the Ketoprofen jar. With the supplied spatula, mix them together until they are mostly dissolved. Transfer the Ketoprofen mix to the jar of RapidPaq Cream Base. Transfer the remaining 1/3 of ethoxy diglycol to the Ketoprofen jar and repeat the mixing process. transfer the remaining Ketoprofen mix to the jar of RapidPaq Cream Base.
4 Complete the Mixing Process
Using the spatula, mix the RapidPaq Crean base jar that now contains the ethoxy diglycol and Ketoprofrn ingredients thoroughly for about 2 minutes or until fully dissolved.
5 Relabel the Resulting Cream
Label the resulting topical cream as required for prescription products. Ensure that the original RapidPaq Cream Base label is removed or obscured, since the original label is no longer accurate once the cream is prepared.
Discard the spatula.
Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the topical cream between 15-30°C (59-86°F). The resulting final topical cream is stable for up to eight weeks.
U.S. Patents Pending
Repacked and Distributed by:
California Pharmaceuticals, LLC
768 Calle Plano
Camarillo, CA 93012
CS113-A1 rev 2
California
PHARMACEUTICALS LLC
