Bosley Md Extra Strength For Men Minoxidil Topical Solution 5%

Bosley Md Extra Strength For Men Minoxidil Topical Solution 5%
SPL v3
SPL
SPL Set ID a62d01da-1488-4e20-e053-2a95a90a286c
Route
TOPICAL
Published
Effective Date 2020-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Propylene Glycol Water Isopropyl Alcohol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-05-21

Description

Minoxidil 5% w/v


Medication Information

Warnings and Precautions

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Dosage and Administration

■ Apply one mL (6 sprays) 2 times a day directly onto the scalp in the area of hair loss

■ Using more or more often will not improve results

■ Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

Description

Minoxidil 5% w/v

Use

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

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 at 2 months with twice a day usage. For some men, 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 not work for all men.

Section 50569-3

Ask a doctor before use if you have heart disease

Section 50570-1

Do not use if

■ You are a woman

■ Your amount of hair loss is dierent than that shown on the side of this carton, or your hair loss is on the front of the scalp. 5% Minoxidil Topical Solution is not intended for frontal baldness or receding hairline.

■ You have no family history of hair loss

■ Your hair loss is sudden and/or patchy

■ You do not know the reason for your hair loss

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

■ Your scalp is red, inflamed, infected, irritated, or painful

■ You use other medicines on the scalp

Section 51727-6

Alcohol, Propylene Glycol, Purified Water

Section 51945-4

Section 53413-1

Questions or comments? Call your helath professionals or BOSLEYMD at 1(800)BOSLEY1

Section 53414-9

May be harmful if used when pregnant or breast-feeding.

Section 55105-1

Hair regrowth treatment for men

Section 55106-9

Minoxidil 5% w/v

Section 60561-8
  • See hair loss pictures on side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep this carton. It contains important information.
  • Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
  • In clinical studies of mostly white men aged 18-19 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
  • Store at controlled room temperature between 68° - 77°F (20°-25°C).

Structured Label Content

Use (USE)

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Dosage and Administration (34068-7)

■ Apply one mL (6 sprays) 2 times a day directly onto the scalp in the area of hair loss

■ Using more or more often will not improve results

■ Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

Warnings and Precautions (34071-1)

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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 at 2 months with twice a day usage. For some men, 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 not work for all men.

Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 50570-1 (50570-1)

Do not use if

■ You are a woman

■ Your amount of hair loss is dierent than that shown on the side of this carton, or your hair loss is on the front of the scalp. 5% Minoxidil Topical Solution is not intended for frontal baldness or receding hairline.

■ You have no family history of hair loss

■ Your hair loss is sudden and/or patchy

■ You do not know the reason for your hair loss

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

■ Your scalp is red, inflamed, infected, irritated, or painful

■ You use other medicines on the scalp

Section 51727-6 (51727-6)

Alcohol, Propylene Glycol, Purified Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call your helath professionals or BOSLEYMD at 1(800)BOSLEY1

Section 53414-9 (53414-9)

May be harmful if used when pregnant or breast-feeding.

Section 55105-1 (55105-1)

Hair regrowth treatment for men

Section 55106-9 (55106-9)

Minoxidil 5% w/v

Section 60561-8 (60561-8)
  • See hair loss pictures on side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep this carton. It contains important information.
  • Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
  • In clinical studies of mostly white men aged 18-19 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
  • Store at controlled room temperature between 68° - 77°F (20°-25°C).

Advanced Ingredient Data


Raw Label Data

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