Active Ingredient(S)
Minoxidil 5%
Minoxidil Topical Solution Liquid
FDA Label NDC 87399-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Growth Essence Llc for the product Minoxidil Topical Solution (NDC 87399-002). 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(s), purpose, use, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hair Regrowth
Use
Uses Regrows hair on the top of the scalp, (vertex
only).
Warnings
For external use only.
Otc - When Using
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 after
2 months with twice daily use. For some people, you
may need to use this product for at least 4 months
before you see results.
Otc - Stop Use
Stop use and ask a doctor if chest pain, rapid
heartbeat, faintness, or dizziness occurs.
Sudden, 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.
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
1. Wet hair and scalp thoroughly.
2. Apply shampoo to the top of the scalp only.
3. Massage gently until a lather forms.
4. Leave on the scalp for 2-3 minutes.
5. Rinse thoroughly.
Other Information
Please keep in a cool place
Inactive Ingredients
Water (Aqua), Sodium Cocoyl Isethionate,Cocamidopro-
pyl Betaine, Sodium Lauroyl Sarcosinate, Propylene
Glycol, Alcohol Denat., Diethylene Glycol Monoethyl
Ether, Glycerin, Polysorbate80, Caffeine, Niacinamide,
Panthenol, Serenoa Serrulata(Saw Palmetto) Fruit
Extract, Aloe Barbadensis Leaf Extract,Persea
Gratissima (Avocado) Oil, Hydrolyzed Keratin,Biotin, Zinc
PCA, Rosmarinus Officinalis (Rosemary) Leaf Extract,
Green Tea Extract, Allium Cepa (Onion) Bulb Extract,
Oleic Acid, Guar Hydroxypropyltrimonium Chloride,
Sodium Chloride,Citric Acid, Phenoxyethanol,
Ethylhexylglycerin, Fragrance.
Do Not Use If
Do not use if: you are allergic to any of the
ingredients in this product
Package Label.Principal Display Panel
Undefined (Label)
* Please review the disclaimer below.
