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 a62d5c00-c56c-4260-e053-2a95a90a30c2
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
Water Isopropyl Alcohol Propylene Glycol

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

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 immediately.

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 health professional 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).
Directions

■ Apply one mL with dropper 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.


Structured Label Content

Use (USE)

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

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 immediately.

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 health professional 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).
Directions (DIRECTIONS)

■ Apply one mL with dropper 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.


Advanced Ingredient Data


Raw Label Data

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