Otc - Active Ingredient
Batana Oil
minoxidil
Flumisch Batana Oil For Hair Growth
FDA Label NDC 85212-0035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Flumisch Batana Oil For Hair Growth for the product Flumisch Batana Oil For Hair Growth (NDC 85212-0035). 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, instructions for use, warnings, dosage & administration, otc - do not use, otc - when using, otc - 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
Otc - Purpose
Hair growth, strengthens hair, repairs damaged hair
Instructions For Use
Apply directly to scalp and hair as pre-shampoo treatment; massage into scalp and leave in for 20-60 minutes before rinsing out with warm water and shampoo/conditioner routine
Warnings
Avoid contact with eyes or mouth
Dosage & Administration
For external use only.
Otc - Do Not 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
May be harmful if used when pregnant or breast-feeding.
Keep out of reach of children, lf swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
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 people, 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 notwork for all men.
Otc - Keep Out Of Reach Of Children
If sxralowed, get medical help or contact a Poison Conirol Cenler ngiht away.
Otc - Stop Use
on broken or irritated scalp
Inactive Ingredient
BATANA
(ROSEMARY) OIL
BIOTIN
BUTYROSPERMUM PARKII (SHEA BUTTER)
BEESWAX
SWEET ALMOND OIL
(JOJOBA) SEED OIL
SILYBUM MARIANUM SEED OIL
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL
OPUNTIA FICUS-INDICA FRUIT EXTRACT
VETIVERIA ZIZANOIDES ROOT OIL
Indications & Usage
Hair loss treatment and growing hair
Package Label.Principal Display Panel
Batana (Batana)
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