|
 PREMIUM DIET
PATCH
Introductions
The Premium Diet Patch is specifically formulated to safely
stimulate your metabolism, causing your body to use and absorb
food more efficiently and to burn fat rather than store it. The
patch will assist in decreasing your appetite as well as
increasing your energy, helping you to lose weight naturally.
Use the Premium Diet Patch every day until you reach your
desired weight. It's safe, natural and easy to use!
Directions
Clean and dry the area
of skin where you wish to apply the patch. Peel the adhesive
backing off of one patch and press the patch firmly against your
skin. Each patch may be worn for three days. It is preferable to
move a new patch to a slightly different location each time.
Replace the patch every three days until you reach your desired
weight. Combine the patch with a healthy diet and regular
exercise for maximum benefits. You can use the Premium Diet
Patch as needed to maintain your desired weight.
Ingredients
The Premium Diet Patch
contains Fucus Vesiculosus, Guarana, Garcinia and Menthol.
Warning: If
you are preganant, nursing, diabetic, have problems with your
thyroid gland, or have any other medicial condion, consult your
physician before using this product.
Supplemental Facts
Fucus Vesiculosus 200mg
Guarana
Extract 125mg
Garcinia
Extract 125mg
*Menthol 50mg
Menthol is
used in patches as a local vasodilator to facilitate transdermal
absorption of the ingredients, but does not absorb significantly
into the bloodstream, therefore is generally not calculated in
total bioavailable content.
MANUFACTURING
PROCESS
PRODUCT
NAME: Premium Diet
Patch
PRODUCT
CODE:TPatch-D
A.
PRODUCT SPECIFICATION
TYPE:
Transdermal
self-adhesive patch
INFUSED ADHESIVE COLOR: Light Brown
SIZE:
1.25” x 1.25”
COMPLETED PATCH
MATRIX
COLOR: Lt.Brown / Pink
B.
MANUFACTURING PROCESS
- Raw
materials received for the Premium Diet Patch are placed in
quarantine until identification tests are completed. If the
material is equivalent to accepted industry standards,
Quality Control will release the material and assign it a
lot number. All ingredients are purchased from such
companies as Hoffman La Roche, BASF, Star West Inc., Bio-Botannica,
Inc., Novel Ingredient Services, Inc., and Botanicals
International. All are certified pharmaceutical or food
grade.
- Upon
release, the raw materials will be weighed out as specified
in the formula. Each weighing is double checked for
accuracy.
- The
active ingredients are blended together geometrically by
weight to assure homogeneity. The matrix of these compounds
is then blended to a uniform and consistent product.
- This
matrix is then introduced into an FDA-approved adhesive in
preparation for coating onto the substrate layer of the
patch. Weight specifications are followed as specified in
the formula.
- The
approved adhesive suspension is then spray-coated onto the
substrate layer, at which point a color match with a coated
substrate standard for patch is verified by Quality Control
to assure batch to batch consistency.
- Coated
substrate layer is then allowed to cure for 24 hours, and a
food-grade waxed paper backing is applied.
-
Completed substrate layer is then slit into uniform strips
and die cut into patches as per specifications. Patches
remain on waxed paper backing as surrounding surplus
material is removed and discarded.
- Quality
Control tests the patch every 1000 pieces during the run.
This assures that the finished patches meet the formula
specification for uniformity and tack of adhesive.
- The
patches are then spooled on to corrugated plastic roll
cores, labeled and bagged for shipping. Samples are then
submitted to Quality Control for laboratory tests.
- Quality
Control then performs identification checks. The finished
product is then released after the laboratory tests are
approved.
CERTIFICATE OF ANALYSIS
PRODUCT NAME:
Premium Diet Patch
Analysis of
Food Supplement “Premium Diet Patch”
Date
Received: 4/22/2005
Number of
Samples: 3
Lot No:
TF954 – LAB1
Sample
Details: Transdermal Polyurethane matrix impregnated with
botanical extracts
Botanical
Extract Detail – As tested; extraction ratio may increase
bioavailability of ingredients:
Bladderwrack Extract (Fucus
vesiculosus)
14.0-mg per 2”x2” patch matrix
Guarana Extract (Paullinia
cupana)
1.2-mg per 2”x2” patch matrix
Menthol
0.5-mg per 2”x2”
patch matrix
Total
elemental breakdown of botanical blend prior to impregnation
onto matrix:
Nitrogen
(%): 03.02
Phosphorus
(%): 00.02
Magnesium
(%): 00.01
Calcium
(%): 00.14
Zinc
(PPM): 11
Copper
(PPM): 07
Iron
(PPM): 221
Iodine
(PPM): 47
Selenium
(PPM): 0.02
MICROBIOLOGICAL
Total
Aerobic Coliforms (cfu/g): <1.0 x 105
Fecal
Coliform (cfu/g): <104
E. Coli (cfu/g):
NEGATIVE
Salmonella:
NEGATIVE
Staphylococci:
NEGATIVE
W.
Operlaggai
NEGATIVE
Listeria:
NEGATIVE
Methods of
Analysis:
Ash: Heating to constant weight at 550°C
(AOAC 938.08 Mod)
APC: Compendium of methods for the Microbiological
Examination of Foods – 3rd edition. 1992
MMPPC: Radio
Immunoassay |
