SPL v1
SPL
SPL Set ID 34dcc43e-3d33-1fb7-e063-6394a90a4d0b
Route
EXTRACORPOREAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (2 g)
Inactive Ingredients
Opuntia Ficus-indica Fruit Juice Vetiveria Zizanoides Root Oil Almond Biotin Beeswax Aqua Davana Oil Silybum Marianum Seed Oil Simmondsia Chinensis (jojoba) Seed Oil Rosemary Oil Butyrospermum Parkii (shea) Butter

Identifiers & Packaging

Pill Appearance
Shape: round
Marketing Status
ANDA Active Since 2025-01-01

Description

Batana Oil minoxidil


Medication Information

Warnings and Precautions

Avoid contact with eyes or mouth

Indications and Usage

Hair loss treatment and growing hair

Dosage and Administration

For external use only.

Description

Batana Oil minoxidil

Section 50565-1

If sxralowed, get medical help or contact a Poison Conirol Cenler ngiht away.

Section 50566-9

on broken or irritated scalp

Section 50567-7

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.

Section 50570-1

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.

Section 51727-6

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

Section 51945-4

Section 55105-1

Hair growth, strengthens hair, repairs damaged hair

Section 55106-9

Batana Oil

minoxidil

Section 59845-8

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


Structured Label Content

Indications and Usage (34067-9)

Hair loss treatment and growing hair

Dosage and Administration (34068-7)

For external use only.

Warnings and Precautions (34071-1)

Avoid contact with eyes or mouth

Section 50565-1 (50565-1)

If sxralowed, get medical help or contact a Poison Conirol Cenler ngiht away.

Section 50566-9 (50566-9)

on broken or irritated scalp

Section 50567-7 (50567-7)

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.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair growth, strengthens hair, repairs damaged hair

Section 55106-9 (55106-9)

Batana Oil

minoxidil

Section 59845-8 (59845-8)

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


Advanced Ingredient Data


Raw Label Data

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