Grofully - 2% Minoxidil Topical Solution

Grofully - 2% Minoxidil Topical Solution
SPL v1
SPL
SPL Set ID d65ea212-d154-2013-e053-2a95a90ab2cc
Route
TOPICAL
Published
Effective Date 2022-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2022-01-24

Description

Minoxidil 2% w/v


Medication Information

Warnings and Precautions

​For external use only

Flammable: Keep away from fire or flame

Description

Minoxidil 2% w/v

Use

to regrow hair on scalp

Section 50565-1

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 hand 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 eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
  • Some people have experienced change in hair color and/or texture. It takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results.
  • The amount of hair regrow is different for each person. This product will not work for all women..
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 that shown on 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, inflammed, infected, irritated, or painful
  • You use other medicines on your scalp
Section 51727-6

Alcohol, Propylene Glycol, Purified Water

Section 51945-4

Section 53413-1

Questions or comments

Call toll-free 1-800-559-7691 or visit grofully.com

Section 53414-9

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

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 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 side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep the carton. It contains important information.
  • In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solutions was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth: 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth: 33% had minimal regrowth).
  • Store at controlled room temperature 68 o - 77 oF (20 o - 25 oC).

Structured Label Content

Use (USE)

to regrow hair on scalp

Warnings and Precautions (34071-1)

​For external use only

Flammable: Keep away from fire or flame

Section 50565-1 (50565-1)

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 hand 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 eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
  • Some people have experienced change in hair color and/or texture. It takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results.
  • The amount of hair regrow is different for each person. This product will not work for all women..
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 that shown on 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, inflammed, infected, irritated, or painful
  • You use other medicines on your 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 toll-free 1-800-559-7691 or visit grofully.com

Section 53414-9 (53414-9)

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

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 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 side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep the carton. It contains important information.
  • In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solutions was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth: 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth: 33% had minimal regrowth).
  • Store at controlled room temperature 68 o - 77 oF (20 o - 25 oC).

Advanced Ingredient Data


Raw Label Data

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