CYCLOPHENE

CYCLOPHENE-
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 Pharmacist Page 1 Page 2

NDC 70332-102-01

For Prescription Compounding Only

Rx only


RapidPaq™
CYCLOPHENE™
(5% cyclobenzaprine hydrochloride 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 111.2 grams of Cyclobenzaprine Hydrochloride 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:
- 5.6 g Cyclobenzaprine Hydrochloride [equivalent to 4.9 g Cyclobenzaprine]

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)
- 5.6 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 Cyclobenzaprine Hydrochloride, ethoxy diglycol and RapidPaq Cream Base. If components are missing or the safety seals are not intact do not use the kit.

2 Prepare for Mixing

Wear gloves and eye protection during mixing operations. Remove the cap and seal from the RapidPaq Cream Base. Break the perforated seal and remove the cap from the Cyclobenzaprine Hydrochloride and ethoxy diglycol.

3 Dissolve the Cyclobenzaprine Hydrochloride

Using a spatula make a well in the center of the RapidPaq Cream Base. Transfer approximately half of the ethoxy diglycol to the Cyclobenzaprine Hydrochloride bottle. Cap the Cyclobenzaprine Hydrochloride bottle and shake to ensure that all residue Cyclobenzaprine Hydrochloride has been dissolved. Pour the contents into the RapidPaq Cream Base. Repeat this step with the remaining ethoxy diglycol.

4 Complete the Mixing Process

Using the spatula, mix the RapidPaq Base jar that now contains the ethoxy diglycol and cyclobenazprine hydrochloride 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 final cream is stable for up to eight weeks.

U.S. Patents Pending

Repackaged and Distributed by:
California Pharmaceuticals, LLC
768 Calle Plano
Camarillo, CA 93012

California PHARMACEUTICALS LLC

CS107-A1 rev 3

Cyclophene instructions
(click image for full-size original)
Cyclophene instructions
(click image for full-size original)

Cyclobenzaprine Hydrochloride product label

Do not use if saety seal is broken

Cyclobenzaprine Hydrochloride

1-propanamine, 3-(5H-dibenzo[a,d]cycloheptenn-5-ylidene)-N,N-dimethyl-, hydrochloride

RxOnly

CAS # 6202-23-9

Net contents 5.6 g

Repackaged by:

California Pharmaceuticals, LLC

Camarillo, CA 93012

California

PHARMACEUTICALS LLC

CS104-A1 rev 1

Cyclobenzaprine label
(click image for full-size original)

RapidPaq Cream Base product label

Do not use if seal is broken

RapidPaq™ Cream base

Net contents: 100 g

Ingredients: (D.l Water, Cetearyl Alcohol, Cyclomethicone, Polysorbate-60, Sorbitol, Phenoxyethanol(and)ethylhexylglycerin, Tocopheryl Acetate,

Aloe barbadensis, Disodium EDTA.)

RX Only

Manufactured for California Pharmaceyticals, LLC, Camarillo, CA 93012

RapidPaq Cream Base
(click image for full-size original)

CYCLOPHENE Kit product label

NDC 70332-102-01

Rx only

RapidPaq™

Kit for Topical Cream

CYCLOPHENE™

(5% cyclobenzaprine hydrochloride topical cream kit)

Muscle relaxant

Store at room temperature,

15-30°C (59-86°F)

Description:

This kit contains active and inactive materials to prepare approximately 111.2 grams of Cyclobenzaprine Hydrochloride 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 ingredient

- 5.6 g Cyclobenzaprine Hydrochloride USP [equivalent to 4.9 g Cyclobenzaprine]

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)

— 5.6 g Ethoxy Diglycol

— Spatula

— Instructions

U.S. Patents Pending

Do not use if safety seal is broken

California

PHARMACEUTICALS LLC

Repacked and Distributed By;

Caifornis Pharmaceuticals, LLC

768 Calle Plano

Camarillo, CA 93012

CS 108-A1 rev 1

Cyclophene Kit
(click image for full-size original)
CYCLOPHENE cyclophene kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70332-102
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70332-102-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 5.6 g
Part 2 1 BOTTLE 5.6 g
Part 3 1 JAR 100 g
Part 1 of 3
ETHOXY DIGLYCOL 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 5.6 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2016
Part 2 of 3
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride powder
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) CYCLOBENZAPRINE HYDROCHLORIDE 5.6 g in 5.6 g
Packaging
# Item Code Package Description Multilevel Packaging
1 5.6 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2016
Part 3 of 3
RAPIDPAQ CREAM BASE rapidpaq cream base cream
Product Information
Route of Administration TOPICAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
CETOSTEARYL ALCOHOL
ETHYLHEXYLGLYCERIN
CYCLOMETHICONE 5
EDETATE DISODIUM
WATER
POLYSORBATE 60
SORBITOL
ALOE VERA LEAF
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 01/01/2016
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 (70332-102), repack (70332-102)

Revised: 07/2016 California Pharmaceuticals LLC

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