Shapiro Md 5% Minoxidil Hair Regrowth Treatment For Men

Shapiro Md 5% Minoxidil Hair Regrowth Treatment For Men
SPL v2
SPL
SPL Set ID 8ec09b28-7f2c-ee32-e053-2995a90a3331
Route
TOPICAL
Published
Effective Date 2019-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2019-07-28

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 right away.

Section 50566-9

Stop use and ask a doctor if

  • Chest pain, rapid heart beat, faintness, or dissiness occurs
  • Sudden, unexplained weight gain occurs
  • Your hands or feet swell
  • Scalp irritation or redness occurs
  • You get unwanted facial hair growth
  • 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 expereinced 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 your 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 different than shown on the side of this carton or 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 or 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?

  • 877-907-4047
  • Visit Website www.shapiromd.com
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

Directions
  • Apply one mL with sprayer 2 times a day directly onto the scalp in the hair loss area
  • 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
Other Information
  • See hair loss pictures on the side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep the carton. It contains important information
  • Hair regrowth has not been shown to last longer than 48 weeks in large clinical trialse with continuous treatment with 5% minoxidil topical solution for men. In clincial studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provide more hair regrowth than 2% minoxidil topical solution
  • Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)

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 right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Chest pain, rapid heart beat, faintness, or dissiness occurs
  • Sudden, unexplained weight gain occurs
  • Your hands or feet swell
  • Scalp irritation or redness occurs
  • You get unwanted facial hair growth
  • 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 expereinced 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 your 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 different than shown on the side of this carton or 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 or 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?

  • 877-907-4047
  • Visit Website www.shapiromd.com
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

Directions (DIRECTIONS)
  • Apply one mL with sprayer 2 times a day directly onto the scalp in the hair loss area
  • 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
Other Information (OTHER INFORMATION)
  • See hair loss pictures on the side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep the carton. It contains important information
  • Hair regrowth has not been shown to last longer than 48 weeks in large clinical trialse with continuous treatment with 5% minoxidil topical solution for men. In clincial studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provide more hair regrowth than 2% minoxidil topical solution
  • Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)

Advanced Ingredient Data


Raw Label Data

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