Label: KETOPHENE kit
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Contains inactivated NDC Code(s)
NDC Code(s): 70332-101-01 - Packager: California Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated July 21, 2016
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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
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RapidPaq™ Cream Base product label
Do not use if seal is broken
California
PHARMACEUTICALS LLC
RapidPaq™ Cream Base
Net contents: 100g
Ingredients: (D.I Water, Cetearyl Alcohol, Cyclomethicone, Polysorbate-60, Sorbitol, Phenoxyethanol(and)ethylhexlglycerin, Tocopheryl Acetate, Aloe Barbadensis, Disodium EDTA
RX Only
Manufactured For California Pharmaceuticals, LLC, Camarillo, CA 93012
- Ethoxy Diglycol product label
- Ketoprofen, USP product label
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Ketophene Kit product label
NDC 70332-101-01
Rx only
RapidPaq™
Kit for Topical Cream
KETOPHENE™
(20% ketoprofen cream kit) Non-Steroid Anti-Inflammatory
Store kit at room temperature,
15-30°C (59-86°F0
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.l Water, Cetearyl Alcohol, Cyclomethicone, Polysorbate-60, Sorbitol, Phenoxyethanol (and) ethylhexylglycerin,
Tocopheryl Acetate, Aloe Barbadensis, Disodium EDTA)
- 33.5g ethoxy diglycol
- Spatula
- Instrustions
U. S. Patents Pending
Do not use if safety seal is broken
California
PHARMACEUTICALS
Repacked and Distributed By:
California Pharmaceuticals, LLC
768 Calle Plano
Camarillo, CA 93012
CS114-A1 rev 2
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INGREDIENTS AND APPEARANCE
KETOPHENE
ketophene kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70332-101 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70332-101-01 1 in 1 KIT 01/01/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 33.5 g Part 2 1 BOTTLE 33.5 g Part 3 1 JAR 100 g Part 1 of 3 ETHOXYDIGLYCOL
diethylene glycol monoethyl ether liquidProduct Information Route of Administration TOPICAL Inactive Ingredients Ingredient Name Strength DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 33.5 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other Part 2 of 3 KETOPROFEN
ketoprofen powder, for suspensionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K) KETOPROFEN 33.5 g in 33.5 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 33.5 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other Part 3 of 3 RAPIDPAQ CREAM BASE
rapidpaq cream base creamProduct Information Route of Administration TOPICAL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE (UNII: NMQ347994Z) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITOL (UNII: 506T60A25R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE SODIUM (UNII: MP1J8420LU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 100 g in 1 JAR; Type 0: Not a Combination Product 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 01/01/2016 Labeler - California Pharmaceuticals, LLC (021420944) Registrant - California Pharmaceuticals, LLC (021420944) Establishment Name Address ID/FEI Business Operations California Pharmaceuticals, LLC 021420944 manufacture(70332-101) , repack(70332-101)
