Active Ingredient
Minoxidil, 5% w/v (in each 1mL dose)
Regenpure Precision Liquid
FDA Label NDC 71290-813
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Salonceuticals, Inc. for the product Regenpure Precision (NDC 71290-813). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose:, use, warnings:, do not use if:, ask a doctor before use if, when using this product:, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Hair Regrowth Topical Treatment
Use
- to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).
Warnings:
• For external use only.
• For use by men only.
• Flammable: Keep away from fire or flame.
Do Not Use If:
• You are a woman.
• Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Solution, 5% is not intended for frontal baldness or receding hairline.
• You have no family history of hair loss.
• Your hair loss is sudden and/or patchy.
• You do not know the reason for your hair loss.
• You are under 18 years of age. Do not use on babies and children.
• Your scalp is red, inflamed, infected, irritated, or painful.
• You use other medications on the scalp.
Ask A Doctor Before Use If
YOU HAVE HEART DISEASE.
When Using This Product:
• Do not apply on other parts of the body.
• Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
• Some people have experienced changes in hair color and/or texture.
• It takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least
4 months before you see results.
• The amount of hair regrowth is different for each person. This product will not work for all men.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Stop Use And Ask Doctor If:
• Side effects occur: You may report side effects to FDA at 1-800-FDA-1088 or to Salonceuticals, Inc. at 1-877-706-8688
• Chest pain, rapid heartbeat, faintness, or dizziness occurs.
• Sudden, unexplained weight gain occurs.
• Your hands or feet swell.
• Scalp irritation occurs, and continues or worsens.
• Unwanted facial hair growth occurs.
Directions:
• Apply 1 mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area.
• Using more or more often will not improve results.
• Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.
Other Information:
• See hair loss pictures on side of this carton.
• Before use, read all information on carton and enclosed booklet.
• Keep the carton, it contains important information.
• Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution 5%.
• In clinical studies with mostly white men age 18-45 years with moderate degrees of hair loss, Minoxidil Topical Solution, 5% provided more hair regrowth than Minoxidil Topical Solution, 2%.
• Store at USP controlled room temperature 20° to 25°C (68° to 77°F).
Inactive Ingredients:
• Alcohol 30% v/v, propylene glycol 50% v/v, purified water
Questions Or Comments?
• Call your health professional or Salonceuticals, Inc. at 1-877-706-8688, Monday—Friday: 9:00am—5:00pm (EST)
Package Labeling:
Label0 (Label0)
* Please review the disclaimer below.
