This US patented formulation (10,265,285) was discovered during a 2-year 4 phase human study at Loma Linda Medical School in California. The ingredients were chosen for their safety and effectiveness. During that study we learned the formulation that was most effective against the bad skin bacteria while sparing the all-important normal bacteria on the human skin. These studies were aimed at controlling the bacteria that causes acne, Propionibacterium acnes which has become a major and puzzling post-operative infection in orthopedic surgery, Dr. Johnson’s medial specialty. As a by-product of those studies it became evident that this formulation would be a benefit in skin health.
The formulation includes the following ingredients:
70% Isopropyl alcohol: This is sold over the counter as “rubbing alcohol”. It is specified by the FDA as an “over the counter” (OTC) label. Most OTC drugs are not reviewed and or approved by FDA, however they may be marketed if they comply with applicable regulations and policies. They have Generally Recognized as Safe designation. (G.R.A.S.).
The Antioxidant: Our AO, protocatechuic acid (PCA) is a powerful anti-oxidant with anti-inflammatory properties. PCA is in the chemical category of benzoic acid. It readily metabolizes in nature to benzoic acid. Benzoic acid is Generally Recognized as Safe (G.R.A.S.) by the FDA as a food additive.
PCA has been designated as Generally Recognized As Safe (GRAS) by the FDA as a flavoring substance for human consumption.
Its FEMA number is 4430 as PCA is chemically listed by its chemical designation; 3, 4 dihydroxybenzoic acid.
Propylene Glycol: Propylene glycol is common additive to foods in the human diet. It is considered by the FDA as Generally Recognized as Safe (G.R.A.S.). When topically applied to the skin it acts to moisten the skin; a humectant.
Essential Oils: Many essential oils are generally recognized as safe (G.R.A.S.) by the FDA and are listed on the following web site.
The list includes those commonly used in AOUSA solutions.
• Grapefruit (Citrus X paradisi)
• Lemon (Citrus limon)
• Lemongrass (Cymbopogon flexuosus)
* Caution: Avoid contact with your eyes and mouth. Do not swallow. Has not been tested on children.
*No parabens and no sulfates.
This PCAUSA formulation is intended for a cosmetic effect. It is a liquid solution consisting of several ingredients, all of which have properties independently and or in combination that are intended for a cosmetic effect.
The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
Therefore this PCAUSA formulation is not intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. This product has not been evaluated by the FDA.
There are many conditions that affect the skin’s beauty and attractiveness. The underlying general conditions are manifested by but not limited to the following: inflammation, infections, aging, and sun damage.
A more extensive list of conditions resulting in loss of beauty and attractiveness are listed at https://www.healthline.com/health/skin-disorders
The influence on beautifying or promoting attractiveness is fundamentally based a solution having properties that include cleaning, anti inflammation, skin moisturizer and a fragrance.
All of these properties are inherent in A Cosmetic. The 70% isopropyl alcohol is a cleansing reagent. The antioxidant provides the anti inflammation property. The propylene glycol has a moisturizing effect. The essential oil provides the fragrance.