Shapiro Md - 2% Minoxidil Hair Regrowth Treatment For Women

Shapiro Md - 2% Minoxidil Hair Regrowth Treatment For Women
SPL v2
SPL
SPL Set ID 8e9c5818-deb9-5c4e-e053-2995a90a1b26
Route
TOPICAL
Published
Effective Date 2019-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (2 mg)
Inactive Ingredients
Isopropyl Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2019-07-28

Description

Minoxidil 2% w/v


Medication Information

Warnings and Precautions

For external use only.

Flamable: Keep away from fire of flame.

Description

Minoxidil 2% w/v

Use

Use to regrow hair on the scalp

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 of feet swell
  • Scalp irritation or redness occurs
  • You do not see hair regrowth in 8 months
Section 50569-3

Ask a doctor before use if you have heart disease

Section 50570-1

Do not use if:

Your degree of hair loss is different than shown on the side of this carton, because this product may not work for you

You have no family history of hair loss

Your hair loss is sudden and/or patchy

Your hair loss is associated with childbirth

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?

  • 1-877-907-4047
  • Visit Website www.shapiromd.com
Section 53414-9

If pregnant or breast feeding, as a healthcare professional before use.

Section 55105-1

Hair regrowth treatment

Section 55106-9

Minoxidil 2% w/v

Directions

Apply 1 mL with dropper 2 times a day directly onto the scalp in the hair loss area

Using more or more ofthen will not improve results

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

Other Information

  • In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal hair regrowth). This compares with the 7% of women reporting moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)
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 women, 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.

Structured Label Content

Use (USE)

Use to regrow hair on the scalp

Warnings and Precautions (34071-1)

For external use only.

Flamable: Keep away from fire of 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 of feet swell
  • Scalp irritation or redness occurs
  • You do not see hair regrowth in 8 months
Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 50570-1 (50570-1)

Do not use if:

Your degree of hair loss is different than shown on the side of this carton, because this product may not work for you

You have no family history of hair loss

Your hair loss is sudden and/or patchy

Your hair loss is associated with childbirth

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?

  • 1-877-907-4047
  • Visit Website www.shapiromd.com
Section 53414-9 (53414-9)

If pregnant or breast feeding, as a healthcare professional before use.

Section 55105-1 (55105-1)

Hair regrowth treatment

Section 55106-9 (55106-9)

Minoxidil 2% w/v

Directions (DIRECTIONS)

Apply 1 mL with dropper 2 times a day directly onto the scalp in the hair loss area

Using more or more ofthen 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)

  • In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal hair regrowth). This compares with the 7% of women reporting moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)
When Using This Product (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 women, 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.

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Raw Label Data

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