All supplement hormone products are bio-Identical extracted from plants, and developed by a Ph.D. chemist as a proprietary product of Specialty Formulations & Manufacturing in Phoenix Arizona.
Karma-Flo hormones are molecularly bio-identical to that which the body makes naturally.Topical hormone creams are absorbed directly into the circulation thus bypassing the liver and therefore allowing for much lower doses than oral preparations.
Dehydroepiandrosterone (DHEA) is a hormone secreted by the adrenal gland. It is a parent hormone which can be converted in the body to either testosterone or estrogen depending on the body’s needs. Natural DHEA levels peak in early adulthood and then slowly decrease as you age.
Topical hormone creams are absorbed directly into the circulation thus bypassing the liver and therefore allowing for much lower doses than oral preparations.
Standard provides 15mg bio-identical DHEA USP per pump.
Karma Flo Bi-Estroderm Cream is a combination of two bioidentical estrogens in a balanced 80/20 ratio of estriol/estradiol. Topical hormone cream is absorbed directly into the circulation thus bypassing the liver and therefore allowing for much lower doses than oral preparations.
Standard Provides 1mg Estriol (E3) and 0.25mg of Estradiol (E2) per pump.
4 fl oz container dispenses 80 pumps
2 fl oz container dispenses 40 pumps
Directions: Apply one full pump 1-2 times per day or as recommended by your health care practitioner. Apply to chest, abdomen, inner arms, or thighs, rotating sites each time.
The reduction of hormone levels during perimenopause and menopause create numerous changes in women’s bodies. Effects can be drastic and include irregular periods, hot flashes, night sweats, thinning hair, vaginal dryness, painful intercourse, irritability, mood swings, mental fog, dry skin, decreased metabolic rate causing weight gain, loss of bone density.
Estriol is the weakest form of estrogen. It is also the safest because it protects against the adverse effects of the stronger estrogens, estradiol and estrone. Studies suggest that it can help reduce a variety of symptoms associated with perimenopause and menopause.
Benefits of estriol include
Topical hormone creams are absorbed directly into the circulation thus bypassing the liver and therefore allowing for much lower doses than oral preparations.
Standard – 0.75 mg estriol/1.5ml meter dosed pump
Progesterone helps to regulate the menstrual cycle, but its main job is to get the uterus ready for pregnancy. Levels naturally begins to fall around the age of 35. Progesterone is the first of the three sex hormones (progesterone, estrogen and testosterone) to decline resulting in an imbalance of estrogen and progesterone known as of estrogen dominance. Symptoms of low progesterone include breast tenderness, headaches, fatigue, lack of libido, depression, anxiety, moodiness, abnormal uterine bleeding, and difficulty conceiving.
Benefits of progesterone include
Topical hormone creams are absorbed directly into the circulation thus bypassing the liver and therefore allowing for much lower doses than oral preparations.
Standard – 20 mg progesterone/1.5ml meter dosed pump
Progesterone offers various benefits, including support for reproductive health, mood regulation, and potentially improved sleep and bone health. It plays a vital role in maintaining a healthy menstrual cycle, supporting pregnancy, and balancing hormones. Progesterone also contributes to brain health, potentially aiding in mood stabilization, anxiety reduction, and even helping with certain cognitive functions
Pregnenolone is a precursor to many of the body’s hormones. As we age its production declines just as the hormones DHEA, progesterone, estrogen and testosterone and decline. Supplementing with pregnenolone can serve to boost production of these hormones.
Pregnenolone, a naturally occurring hormone in the body, is a precursor to many other hormones, including DHEA, progesterone, estrogen, testosterone, and cortisol. It is also synthesized in the brain and nervous system, where it acts as a neurosteroid and can modulate various brain functions. Here are some potential benefits associated with pregnenolone:
Made in the USA. Karma Flo products are manufactured under the strict guidelines of the U.S. Food and Drug Administration’s Good Manufacturing Practices (GMP). Karma Flo products have not been evaluated by the FDA and are not intended to diagnose, treat, or prevent any disease.
Inactive ingredients of all creme applications: Purified water, Aloe Barbadensis Gel, Glycerin, Isopropyl Palmitate, Stearic Acid, Caprylic/Capric Triglycerides, Glyceryl Stearate, Emulsifying Wax NF, Phenoxyethanol, Sodium Bicarbonate, Potassium Sorbate, Allantoin, Lecithin, Oenothera Biennis (Evening Primrose), Tocopherol.
Directions:
Use Only As Directed or as recommended by your health care professional.
Apply to chest, abdomen, inner arms or thighs, rotating sites each time.
Menstruating Women Apply a full pump once or twice a day as needed, starting on the 12th day after the first day of menstrual flow thru the 28th day.
Menopausal or Post-Menopausal Women: Apply a full pump once or twice a day for a maximum of 21 consecutive days/month.
FDA Topical Dosage Considerations:
The average amount of estrogen in a 25-year-old woman varies throughout her menstrual cycle, but generally falls within the range of 30 to 400 pg/mL (picograms per milliliter). This is considered within the normal range for pre-menopausal women
The pump dispenser is metered to deliver the exact amount of hormones for each pump. Therefore, the FDA requirements are in compliance to obviate the requirement for a prescription, and the product qualifies to be sold cover-the-counter.
Naturally derived bio-identical HRT products for menopause are not typically sold over-the-counter (OTC) without a prescription because they they are most often administered by ingestion, or injection. However our affiliate company is also private labeling our proprietary product to other vendors-- which are requiring prescriptions, and selling the product at a 200% to 300% higher price than OTC.
Although the FDA regulates compounded bio-identical hormone replacement therapy (B-HRT) that is administered topically, the FDA has already established a "Monograph", which would not only include the chemical, but also the dosages and manner of application. Topical application at a pre-measured dosage, is exempt from FDA compliance with the necessity of performing a "Time and Extent" (T&E) study and application required when a nonprescription (over-the-counter or OTC) drug product has been marketed in the United States for a "material time" and to a "material extent".
This allows the drug to be considered GRAS (generally recognized as safe) under the OTC monograph system, potentially avoiding the need for an extensive and expensive T&E study, or a full New Drug Application (NDA), or a duplicating a previous time and extent study.
While some products marketed as "bioidentical" are available OTC, they source the constituent chemical manufacturer produced bio-compatible compositions as used in the prescription formulations, as B-HRT as a derivative of natural substances. They are therefore exempt from the regulation of the FDA's product registration processes, which basically require the oversight by a physician, and therefore a prescription
The following is a more detailed explanation:
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1. FDA Regulation and Compounding Pharmacies:
2. Over-the-Counter Options:
3. Why Prescription is Usually Required:
Bio-identical hormones are hormones that are structurally and chemically exact duplicates of the hormones naturally produced by your body.
They are derived from plant sources such as yams and soybeans and are designed to mimic the molecular structure of hormones such as estrogen, progesterone, and testosterone. Generally speaking, bio-identical hormones are safer and more effective than synthetic hormones made by large-scale pharmaceutical labs.
But because they are “made to order,” it’s important to note that not all bio-identical hormones are created equal.
While bio-identical hormones may be considered safer than traditional HRT, the quality and purity of compounded bio-identical hormones can vary depending on the compounding pharmacy. That is why one must place a reliance on the reputation of the manufacturer by their FDA credentials as a manufacturer.
Whatever your need or the size of your project, we commit to your satisfaction every step of the way. Our job is to produce the best possible product at the most competitive price in order to make your business successful. We truly commit to our client’s advancement and look to provide long term partnerships that provide sustainability, consistency and profitability.
SFM provides product research, development and manufacturing services in the health care and beauty products segment. We specialize in skin and personal care products, over the counter (OTC) products and nutraceutical supplements.
SFM has over 30 years of combined experience in the formulation and manufacture of nutraceutical supplements, health & beauty products and OTC medications.
Our highly qualified experts and experienced professionals are able to create advanced formulations using the highest quality natural ingredients that are safe, effective and based on the latest in cutting edge research and compounding science.
Our reliable specialty formulations ensure profitability and customer satisfaction, enabling you to compete in the business world with lower volumes and higher margins.
We take pride in providing the highest level of individualized customer care servicing customers worldwide including the United States, Canada, South America, European Union, Africa, Middle East and Asia.
Our facility in Phoenix is an FDA Registered, AZ Board of Pharmacy Approved Private Label Manufacturer.
Some of our proprietary formulations available for your choice of packaging, can be found here...