KETOPHENE

KETOPHENE-
California Pharmaceuticals, LLC

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.

Instructions for Preparation Page 1 Page 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
(click image for full-size original)

Ketophehe Kit Instructions 2
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)
KETOPHENE
ketophene kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70332-101
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70332-101-01 1 KIT in 1 KIT None
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 liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
DIETHYLENE GLYCOL MONOETHYL ETHER
Packaging
# Item Code Package Description Multilevel Packaging
1 33.5 g in 1 BOTTLE None
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 suspension
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOPROFEN (KETOPROFEN) KETOPROFEN 33.5 g in 33.5 g
Packaging
# Item Code Package Description Multilevel Packaging
1 33.5 g in 1 BOTTLE None
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 cream
Product Information
Route of Administration TOPICAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
CETOSTEARYL ALCOHOL
CYCLOMETHICONE
POLYSORBATE 60
SORBITOL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
.ALPHA.-TOCOPHEROL ACETATE
ALOE VERA LEAF
EDETATE SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 100 g in 1 JAR None
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 Operations
California Pharmaceuticals, LLC 021420944 manufacture (70332-101), repack (70332-101)

Revised: 07/2016 California Pharmaceuticals, LLC

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