84614-003 5% Minoxidil Hair Growth Foam With Biotin

84614-003 5% Minoxidil Hair Growth Foam With Biotin
SPL v2
SPL
SPL Set ID 21bb47c4-47c3-df7c-e063-6394a90abe15
Route
TOPICAL
Published
Effective Date 2024-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Biotin (0.5 g) Minoxidil (5 g)
Inactive Ingredients
Butane Alcohol Water Anhydrous Citric Acid Lactic Acid Cetyl Alcohol Glycerin Stearyl Alcohol Polysorbate 80 .alpha.-tocopherol Isobutane Castor Oil Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-10

Description

5% Minoxidil Hair Growth Foam with Biotin


Medication Information

Warnings and Precautions

Flammable:keep away from fire or flame.

Keep out of reach of children.

For exlernal use oniy

Indications and Usage

Use to regrow hair of the scalp

Dosage and Administration

1.Shake the bollle, hold it upside down and genlly press the walve to dispensefoam onio your hand, approximalely the size of half a capful

2.Massage the foam inio your gcalp with your fngers, paring your hair intorows to ensure even application to areas with thinning hair. Then, wash yourhands thoroughly.

3.Use Twice Daily and enjoy thicker, fuler hair gronth in as lille as 3 to 6months.

Description

5% Minoxidil Hair Growth Foam with Biotin

Section 42229-5

5% Minoxidil Hair Growth Foam with Biotin

Section 44425-7

Before use, read al informglion on carton and enclosed leale.Store at conlrolled room temperalure 20° lo 25°℃ (68° to 77°F)Do not incinerale container. Do not expose to heat or slore at lemperalureabove 104° F(40°C).

Section 50565-1

Keep out of reach of children.lf swalkwed, get medical help or contac a Poison Conlrol Cenler(1-800-222-1222) right away.

Section 50566-9

Chest pain, rapid hearibeat, aininegs, or dizziness oocurs.

Sudden, unexplained weight gain oocurs.

If umwaneed facil har growth occurs .

lf you do nat see hair regrowth in 6 months.

Section 50567-7

Awoid contact with the eyes. in case of accidenlal conlact, rinse eyes withlarge amcunts of cool tap waler.

Some people have experienced changes in hair color andlor lexture.

It takes time lo regrow hair, Resuts may ooour at 3 monihs with twice a dayusage. For some men, you may need to use this product for at least 6 monlhsbefore you see results. The amount of hair regrowih is diferent for eachpergon.

Awoid contact with eyes. in case of aocidenlal contact, rinse eyes with alarge amcunt of cool tap waler.

Section 50570-1

Your hair loss is gudden andlor palchy.

Your hair loss is associald with chidbinth.

You do nol knaw the reason for your hair logs.

You are under 18 years of age. Do not use on babies and children.

Your gcalp is red, intamed, infecled, irritated, or painfu.

You use other medicines on the scalp.

Section 51727-6

ALCOHOL

GLYCERIN

CETYL ALCOHOL

STEARYL ALCOHOL

POLYSORBATE 80

ANHYDROUS CITRIC ACID

LACTIC ACID

CASTOR OIL

.ALPHA.-TOCOPHEROL

EDETATE DISODIUM

ISOBUTANE

BUTANE

WATER

Section 51945-4

Section 55105-1

Hair Regrowih Treaiment

Section 55106-9

Minoxidil 5%

Biotin 0.5%


Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair of the scalp

Dosage and Administration (34068-7)

1.Shake the bollle, hold it upside down and genlly press the walve to dispensefoam onio your hand, approximalely the size of half a capful

2.Massage the foam inio your gcalp with your fngers, paring your hair intorows to ensure even application to areas with thinning hair. Then, wash yourhands thoroughly.

3.Use Twice Daily and enjoy thicker, fuler hair gronth in as lille as 3 to 6months.

Warnings and Precautions (34071-1)

Flammable:keep away from fire or flame.

Keep out of reach of children.

For exlernal use oniy

Section 42229-5 (42229-5)

5% Minoxidil Hair Growth Foam with Biotin

Section 44425-7 (44425-7)

Before use, read al informglion on carton and enclosed leale.Store at conlrolled room temperalure 20° lo 25°℃ (68° to 77°F)Do not incinerale container. Do not expose to heat or slore at lemperalureabove 104° F(40°C).

Section 50565-1 (50565-1)

Keep out of reach of children.lf swalkwed, get medical help or contac a Poison Conlrol Cenler(1-800-222-1222) right away.

Section 50566-9 (50566-9)

Chest pain, rapid hearibeat, aininegs, or dizziness oocurs.

Sudden, unexplained weight gain oocurs.

If umwaneed facil har growth occurs .

lf you do nat see hair regrowth in 6 months.

Section 50567-7 (50567-7)

Awoid contact with the eyes. in case of accidenlal conlact, rinse eyes withlarge amcunts of cool tap waler.

Some people have experienced changes in hair color andlor lexture.

It takes time lo regrow hair, Resuts may ooour at 3 monihs with twice a dayusage. For some men, you may need to use this product for at least 6 monlhsbefore you see results. The amount of hair regrowih is diferent for eachpergon.

Awoid contact with eyes. in case of aocidenlal contact, rinse eyes with alarge amcunt of cool tap waler.

Section 50570-1 (50570-1)

Your hair loss is gudden andlor palchy.

Your hair loss is associald with chidbinth.

You do nol knaw the reason for your hair logs.

You are under 18 years of age. Do not use on babies and children.

Your gcalp is red, intamed, infecled, irritated, or painfu.

You use other medicines on the scalp.

Section 51727-6 (51727-6)

ALCOHOL

GLYCERIN

CETYL ALCOHOL

STEARYL ALCOHOL

POLYSORBATE 80

ANHYDROUS CITRIC ACID

LACTIC ACID

CASTOR OIL

.ALPHA.-TOCOPHEROL

EDETATE DISODIUM

ISOBUTANE

BUTANE

WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair Regrowih Treaiment

Section 55106-9 (55106-9)

Minoxidil 5%

Biotin 0.5%


Advanced Ingredient Data


Raw Label Data

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