Otc - Active Ingredient
Minoxidil 5%
Minoxigaine
FDA Label NDC 72965-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hairgenics Llc for the product Minoxigaine (NDC 72965-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, directions, other information, other ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hair Regrowth Treatment for Men
Indications & Usage
Warnings
For external use only.
Flammable: Keep away from fire or flame
Do not use if:
• You have no family history of hair loss
• Your hair loss is sudden and/or patchy
• Your hair loss is associated with childbirth
• 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, irritated or painful
• You use other medicines 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 tap water
• Some people have experienced changes in hair color and/or texture it takes time to regrow hair.
• You may need to use this product 2 times a day for at least 4 months before you see results
• The amount of hair regrowth is different for each person.
• This product may not work for everyone.
Stop use and/or ask a doctor if
• Chest pain, rapid heartbeat, faintness, dizziness or unexplained weight gain occurs
• Your hands or feet swell
• Scalp irritation or redness occurs
• Unwanted facial hair growth occurs
• You do not see hair regrowth in 4 months
May be harmful is used when pregnant or breast-feeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Using dropper, apply one mL directly onto the scalp in the hair loss area
For best results use twice daily on dry towel dried hair.
Use fingertips to massage solution into skin
Other Information
• Store at controlled room temperature 68° to 77°F (20°- 25°C)
Other Ingredients
Azelaic Acid, Retinol, Caffeine, Biotin, Saw Palmetto Extract, Nettle Extract 10:1, Pygeum Bark Extract, Water, SD Alcohol, Propylene Glycol, Gransolve DMI, Fresh Blue Agave, Zinc Sulfate, Vitamin B6.
Otc - Questions
Questions or comments:
1-281-454-3563
Principal Display Panel
Minoxigaine (Minoxigaine 171107o)
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