Hair Restore Ultra Scalp Solution (Minoxidil / Azelaic Acid / Finasteride / Ketoconazole) (60 mL)

Hair Restore Ultra Scalp Solution is a topical treatment designed to combat hair thinning and hair loss, often targeting more advanced stages of androgenetic alopecia (male and female pattern baldness) or other hair loss conditions. The formulation is typically stronger than standard versions, offering more concentrated active ingredients like Minoxidil or Finasteride, along with other supportive compounds to enhance hair growth.
The “Ultra” version is formulated to provide faster results and target stubborn or severe hair loss, improving hair density, strength, and thickness.

1. Minoxidil (Primary Active Ingredient)
⦁ Vasodilation: Minoxidil works by increasing blood flow to the scalp, which enhances oxygen and nutrient delivery to hair follicles, encouraging hair growth.
⦁ Prolongs Anagen Phase: It helps extend the anagen phase (the growth phase) of the hair cycle, leading to thicker and longer hair.
⦁ Follicle Reactivation: Minoxidil is effective in reactivating dormant or miniaturized hair follicles, promoting the regeneration of hair growth.
2. Finasteride (If Included)
⦁ Prevents Further Hair Loss: By reducing DHT levels, Finasteride helps to stabilize hair follicles, preventing further hair loss while supporting regrowth.
3. Supporting Ingredients (If Present)
⦁ Biotin: Supports the keratin structure of hair, improving its strength and appearance.
⦁ Caffeine: May stimulate the hair follicles and counteract DHT’s damaging effects.
⦁ Ketoconazole: If included, it helps reduce scalp inflammation and fungal buildup, promoting a healthier scalp environment for hair growth.

Contraindications
⦁ Allergy to Minoxidil, Finasteride, or Other Ingredients: Do not use if allergic to any of the components in the solution.
⦁ Scalp Conditions: Avoid using the product on areas of the scalp with cuts, infections, or open wounds.
⦁ Children Under 18: Not recommended for use in children unless prescribed by a healthcare provider.
⦁ Pregnancy: Not advised for use during pregnancy (see “Pregnancy & Breastfeeding” section).
Precautions
⦁ Sensitive Skin: Test the product on a small patch of skin before full application, especially for people with sensitive scalps.
⦁ Dosage: Apply only as directed. Overuse or incorrect application may lead to increased risk of side effects.
⦁ Other Treatments: Before using in combination with other scalp treatments, consult with a healthcare provider to avoid interactions or excessive irritation.
⦁ Cardiovascular Conditions: Individuals with heart disease or high blood pressure should consult a doctor before using Minoxidil.

Common Side Effects
⦁ Initial Shedding: Some users may experience temporary hair shedding during the first few weeks of use as old hairs are replaced by new growth.
⦁ Dryness or Flaking: This may occur due to the alcohol or other solvents used in the formulation.
Less Common Side Effects
⦁ Unwanted Hair Growth: If the solution unintentionally spreads to other areas (e.g., forehead), it may lead to unwanted facial or body hair growth.
⦁ Dizziness or Light-headedness: Some individuals may feel light-headed, especially when standing up quickly, due to systemic absorption of Minoxidil.
⦁ Headaches: Headaches can occasionally occur, particularly when first using the solution.
Serious Side Effects (Rare)
⦁ Chest Pain: A sign of systemic absorption, which can affect the cardiovascular system.
⦁ Heart Palpitations: Rapid heartbeat or irregular rhythms.
⦁ Swelling: Unusual swelling of the face, lips, or limbs, which may indicate an allergic reaction.
⦁ Severe Skin Reactions: Rash, peeling, or severe irritation in the area of application.
⦁ If any of these serious side effects occur, it’s important to stop using the solution and seek medical attention immediately.

Pregnancy
⦁ Not recommended during pregnancy.
⦁ The effects of Minoxidil on a developing fetus are not well-studied, and its use is generally advised against in pregnant individuals due to potential risks.
Breastfeeding
⦁ Caution is advised.
⦁ There is insufficient evidence regarding the excretion of Minoxidil into breast milk. Therefore, it is important to consult with a healthcare provider before using the product while breastfeeding, as it may pose a risk to the infant.

Store this medication in its original container at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.

1. DeVillez RL. The Therapeutic Use of Topical Minoxidil. Dermatol Clin 1990;8:367-74.
2. Olsen EA, Dunlap FE, Funicella T, et al. A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men. J Am Acad Dermatol 2002;47:377-85.
3. Olsen EA, Whiting D, Bergfeld W, et al. A multicenter, randomized, placebo-controlled, double-blind clinical trial of a novel formulation of 5% minoxidil topical foam versus placebo in the treatment of androgenetic alopecia in men. J Am Acad Dermatol 2007;57(5):767-74. Epub 2007 Aug 29
4. Finacea (azelaic acid) topical gel package insert. Whippany, NJ: Bayer Healthcare; 2016 Aug.
5. Azelex (azelaic acid cream) 20% [package insert]. Irvine, CA: Allergan; 2013.
6. Finacea (azelaic acid) 15% topical foam package insert. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2015 Jul.
7. Proscar (finasteride) package insert. Whitehouse Station, NJ: Merck and Co.; 2014 Jan.
8. Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003:349:213-22.
9. FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer. Retrieved June 9, 2011. Available on the World Wide Web at: http://www.fda.gov/Drugs/DrugSafety/ucm258314.htm– LinkOpens in New Tab
10. Ketoconazole tablets package insert. Morgantown, WV: Mylan Pharmaceuticals, Inc.; 2017 Sept.
11. Nizoral (ketoconazole shampoo) package insert. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2017 Dec.
12. Nizoral (ketoconazole) package insert. Titusville, NJ: Janssen Pharmaceutica Products, L.P.; 2006 Aug.
13. Food and Drug Administration MedWatch. FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems. Retrieved July 26th, 2013. Available on the World Wide Web https://www.fda.gov/Drugs/DrugSafety/ucm362415.htm– LinkOpens in New Tab
14. Food and Drug Administration MedWatch. FDA Drug Safety Communication: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death. Retrieved May 19th, 2016. Available on the World Wide Web https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm502073.ht– LinkOpens in New Tab
15. Bauer JH, Alpert MA. Rapid reduction of severe hypertension with minoxidil. J Cardiovasc Pharmacol 1980;2 Suppl:S189-99.
16. Alpert MA, Bauer JH. Rapid control of severe hypertension with minoxidil. Arch Intern Med 1982;142(12):2099-104.
17. Pogatsa-Murray G, Varga L, Varga A, et al. Changes in left ventricular mass during treatment with minoxidil and cilazapril in hypertension patients with left ventricular hypertrophy. J Hum Hypertens 1997;11(3):149-56.
18. Buhl AE. Minoxidil’s action in hair follicles. J Invest Dermatol 1991;96:73S-4S.
19. Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol 2004;150:186-194.
20. Sato T, Tadokoro T, Sonoda T, et al. Minoxidil increases 17b-hydroxysteroid dehydrogenase and 5a-reductase activity of cultured human dermal papilla cells from balding scalp. J Derm Sci 1999;19:123-5.
21. Como JA, Dismukes WE. Oral azole drugs as systemic antifungal therapy. N Engl J Med 1994;330:263-72.
22. Borgers M. Mechanism of action of antifungal drugs, with special reference to the imidazole derivatives. Rev Inf Dis. 1980;2:520-34.
23. Sonino N. The use of ketoconazole as an inhibitor of steroid production. N Engl J Med 1987;317:812-8.
24. Pont A, Williams PL, Loose DS, et al. Ketoconazole blocks adrenal steroid synthesis. Ann Intern Med 1982;97:370-2.
25. Trachtenberg J, Pont A. Ketoconazole therapy for advanced prostate cancer. Lancet 1984;433-5.
26. Yu M, Tomasa G. A double-blind, prospective, randomized trial of ketoconazole, a thromboxane synthetase inhibitor, in the prophylaxis of the adult respiratory distress syndrome. Crit Care Med 1993;21:1635-42.
27. Loniten (minoxidil) tablets package insert. Kalamazoo, MI: Pharmacia; 2006 Feb.
28. Health Care Financing Administration. Interpretive Guidelines for Long-term Care Facilities. Title 42 CFR 483.25(l) F329: Unnecessary Drugs. Revised 2015.
29. Propecia (finasteride) package insert. Whitehouse Station, NJ: Merck and Co., INC.; 2013 Sept.
30. Amory JK, Wang C, Swerdloff RS, et al. The effect of 5-alpha-reductaxe inhibition with dutasteride and finasteride on semen parameters and serum hormones in healthy men. J Clin Endocrin Metab 2007;92(5):1659-65
31. Roden, DM. Drug-induced prolongation of the QT interval. New Engl J Med 2004;350:1013-22.
32. Crouch MA, Limon L, Cassano AT. Clinical relevance and management of drug-related QT interval prolongation. Pharmacotherapy 2003;23:881-908.
33. Benoit SR, Mendelsohn AB, Nourjah P, et al. Risk factors for prolonged QTc among US adults: Third National Health and Nutrition Examination Survey. Eur J Cardiovasc Prev Rehabil 2005;12(4):363-368.
34. Koide T, Ozeki K, Kaihara S, et al. Etiology of QT prolongation and T wave changes in chronic alcoholism. Jpn Heart J 1981;22:151-166.
35. van Noord C, Eijgelsheim M, Stricker BH. Drug- and non-drug-associated QT interval prolongation. Br J Clin Pharmacol 2010;70(1):16-23.
36. Galli-Tsinopoulou A, Chatzidimitriou A, Kyrgios I, et al. Children and adolescents with type 1 diabetes mellitus have a sixfold greater risk for prolonged QTc interval. J Pediatr Endocrinol Metab 2014;27:237-243.
37. Ketoconazole cream package insert. Suwanee, GA: Tiber Laboratories; 2010 Apr.
38. Extina (ketoconazole foam) package insert. Morgontown, WV: Mylan Pharmaceuticals, Inc.; 2018 Jun.
39. Xolegel (ketoconazole gel) package insert. Exton, PA: Almirall, LLC; 2019 Dec.
40. Kaler SG, Patrinos ME, Lambert GH, et al. Hypertrichosis and congenital anomalies associated with maternal use of minoxidil. Pediatrics 1987;79:434-6.
41. Minoxidil tablets package insert. Corona, CA: Watson Laboratories, Inc; 2009 Jun.
42. Azelex (azelaic acid) package insert. Irvine, CA: Allergan, Inc.; 2004 May.
43. US Public Health Service (USPHS) and the Infectious Diseases Society of America (IDSA). The Living Document: Guidelines for the Preventing Opportunistic Infections Among HIV-Infected Persons. Retrieved November 28, 2001. Available on the World Wide Web at www.aidsinfo.nih.gov.
44. American Academy of Pediatrics (AAP) Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics 2001;108(3):776-789.
45. Valdivieso A, Valdes G, Spiro TE, et al. Minoxidil in breast milk. Ann Intern Med. 1985;102:135. Letter.
46. Azelex (azelaic acid) package insert. Irvine, CA: Allergan, Inc.; 2004 May.
47. Moretti ME, Ito S, Koren G. Disposition of maternal ketoconazole in breast milk. Am J Obstet Gynecol. 1995;173:1625-1626.
48. Green L, Wysowski DK, Fourcroy JL. Gynecomastia and breast cancer during finasteride therapy. N Engl J Med 1996;335:823.
49. Xolegel (ketoconazole gel) package insert. Exton, PA: Almirall, LLC; 2019 Dec.