A Comparative Study to Evaluate Two Air-Activated Adhesive Backed Heat Patches

Inclusion Criteria:

- Subjects who complete an appropriately administered informed consent process that
includes signing the IRB-approved consent form;

- subjects 18-75 years old of each sex;

- are of any skin type or race, providing the skin pigmentation will allow discernment
of erythema;

- subjects who are in good general health and free of any disease state or physical
condition;

- subjects who are willing and able to have the study products applied as directed, and
comply with study instructions;

- subjects must be willing to restrict their activity for the 8 hour patch wear time so
that patches and thermocouples do not come loose;

- subjects must be willing to wear a pouch containing the thermologger and thermocouple
wiring for the entire 8 hours;

- subjects who are 55 years or older agree to wear a t-shirt provided by the site for
the entire 8 hour patch wear time.

Exclusion Criteria:

- Subjects who are pregnant or nursing;

- subjects with excessive hair at the application site, scar tissue, tattoo or
coloration that would interfere with the placement of the study product or the skin
assessment;

- subjects with diabetes or poor circulation or have any clinically significant chronic
illness which could place the subject at increased risk during participation or
result in inappropriate dermal response during the study;

- subjects unable to feel pain or heat (e.g., subjects with neuropathy);

- subjects with active dermatitis (including sunburn) in the treatment area or other
visible dermatological disease which, in the investigator's opinion, might interfere
with the response to the study products or interfere with the skin assessments
associated with the study products;

- have history of significant dermatologic cancers or neoplasms in the treatment area;

- subjects who have used topical dermatological products in the application area within
24 hours prior to anticipated study product application;

- subjects using a concomitant medication that, in the investigator's opinion, could
interfere with the interpretation of the study results. Examples of such drugs
include vasoactive (constrictor or dilator) medications, prescription or OTC, that
could modulate blood flow, within 24 hours prior to or during the application of
study products, including nitroglycerin, non-steroidal anti-inflammatory products
(NSAIDs, e.g., ibuprofen, aspirin (<=81 mg/day is acceptable)), topical
corticosteroids and OTC cough/cold products including antihistamines and/or either
phenylpropanolamine or phentolamine;

- subjects who have used systemic steroids (i.e., oral, IV, IM or intra-articular) 30
days prior to the application of test articles (intranasal/inhaled steroids are
acceptable);

- subjects who have received an investigational medication or device within 30 days
prior to enrollment into this study;

- subjects who have a history of sensitivity to any of the study products or adhesion
materials;

- subjects who are currently participating in an investigational study;

- subjects who are known to be noncompliant or are unlikely to comply with the
requirements of the study protocol (e.g., due to alcoholism, product dependency,
mental incapacity) in the opinion of the investigator.