Label: KETOPHENE kit

  • NDC Code(s): 70332-101-01
  • Packager: California Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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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

    Ketophehe Kit Instructions 1

    Ketophehe Kit Instructions 2

  • 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

    RapidPaq Label

  • Ethoxy Diglycol product label

    Do not use if safety seal is broken

    Ethoxy Diglycol

    Diethyl Glycol Monoethly Ether

    CAS # 111-90-0

    Net contents 33.5 g

    Rx Only

    Repackaged By;

    California Pharmaceuticals, LLC

    Camarillo, Ca 93012

    California

    PHARMACEUTICALS LLC

    cs112-A1 rev 1

    Ethoxy Diglycol Label

  • Ketoprofen, USP product label

    Do not use if seal is broken

    Ketoprofen, USP

    C16H14O3 CAS # 22071-15-4

    Net contents: 33.5 g

    California

    PHARMACEUTICALS

    RX Only

    Repackaged by California Pharmaceuticals, LLC, Camarillo, CA 93012

    CS110-A1 rev 1

    Ketoprofen USP Label

  • 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

    Ketophene Kit

  • INGREDIENTS AND APPEARANCE
    KETOPHENE 
    ketophene kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70332-101
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70332-101-011 in 1 KIT01/01/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 33.5 g
    Part 21 BOTTLE 33.5 g
    Part 31 JAR 100 g
    Part 1 of 3
    ETHOXYDIGLYCOL 
    diethylene glycol monoethyl ether liquid
    Product Information
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    133.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Part 2 of 3
    KETOPROFEN 
    ketoprofen powder, for suspension
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K) KETOPROFEN33.5 g  in 33.5 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    133.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Part 3 of 3
    RAPIDPAQ CREAM BASE 
    rapidpaq cream base cream
    Product Information
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2016
    Labeler - California Pharmaceuticals, LLC (021420944)
    Registrant - California Pharmaceuticals, LLC (021420944)
    Establishment
    NameAddressID/FEIBusiness Operations
    California Pharmaceuticals, LLC021420944manufacture(70332-101) , repack(70332-101)