mdhair for women minoxidil 2%

mdhair for women minoxidil 2%
SPL v2
SPL
SPL Set ID c3ba93d7-e826-f6ac-e053-2a95a90a7951
Route
topical
Published
Effective Date 2021-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
minoxidil (2 g)
Inactive Ingredients
propylene glycol water isopropyl alcohol

Identifiers & Packaging

Marketing Status
anda active Since 2021-06-01

Description

Minoxidil 2% w/v


Medication Information

Warnings and Precautions

For external use only.

Flammable: Keep away from fire or flame

Active Ingredient

Minoxidil 2% w/v

Dosage and Administration

• apply one 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 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 regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).

• store at USP controlled room temperature 20º to 25ºC (68º to 77ºF)

Description

Minoxidil 2% w/v

Use

to regrow hair on the scalp (vertex only, see picture on side of carton)

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9
  • 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

• 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 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. This product will not work for all women.

Section 50569-3

heart disease

Section 50570-1

• your amount of hair loss is different than that 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 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

Call MDalgorithms Inc. at; 1-833-257-1914

or contact us at; [email protected]

Section 53414-9

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

Section 55105-1

Hair regrowth treatment


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Flammable: Keep away from fire or flame

Active Ingredient (55106-9)

Minoxidil 2% w/v

Dosage and Administration (34068-7)

• apply one 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 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 regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).

• store at USP controlled room temperature 20º to 25ºC (68º to 77ºF)

Use (USE)

to regrow hair on the scalp (vertex only, see picture on side of carton)

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)
  • 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)

• 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 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. This product will not work for all women.

Section 50569-3 (50569-3)

heart disease

Section 50570-1 (50570-1)

• your amount of hair loss is different than that 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 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)

Call MDalgorithms Inc. at; 1-833-257-1914

or contact us at; [email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Hair regrowth treatment


Advanced Ingredient Data


Raw Label Data

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