Active Ingredient
Minoxidil 5% w/v
Valbello Solution
FDA Label NDC 87942-0001
13 label sections · Submitted to the FDA by Valbello Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Valbello Llc for the product Valbello (NDC 87942-0001). 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, uses, do not use, warnings, ask a doctor before use if, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hair regrowth treatment
Uses
Helps regrow hair on the scalp.
Do Not Use
* if you have no family history of hair loss
* if your hair loss is sudden and/or patchy
* if you do not know the reason for your hair loss
* if you are under 18 years of age
* if your scalp is red, inflamed, infected, irritated, or painful
* if you use other medicines on the scalp
Warnings
For external use only
Ask A Doctor Before Use If
You have heart disease.
When Using This Product
- do not use more than directed
- do not apply on other parts of the body
- avoid contact with the eyes; if contact occurs, rinse with large amounts of cool tap water
Stop Use And Ask 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
Keep Out Of Reach Of Children
If swallowed, get medical help or contac a Posion Control Center right away.
Directions
Apply 1 ml 2 times a day directly onto the scalp inn the hair loss area.
Other Information
Store at controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.
Inactive Ingredients
Water, Propylene Glycol, Ethyl Alcohol, DMDM Hydantoin, Phenoxyethanol, Benzyl Alcohol, Hydroxyacetophenone, Castor Oil, Bergamot Oil.
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label
Valbello Minoxidil 5% Hair Regrowth Treatment Label (Valbello2)
* Please review the disclaimer below.
