Nutrastim Hair Regrowth Treatment For Women

Nutrastim Hair Regrowth Treatment For Women
SPL v3
SPL
SPL Set ID 53f66d84-c5b2-1a90-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (20 g)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2017-06-29

Description

To regrow hair on the scalp.


Medication Information

Warnings and Precautions
  • For external use only.
  • For use by women only.
  • Flammable. Keep away from fire or flame.
Description

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. (1-800-222-1222).

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 with 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
  • Your degree 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 child birth.
  • 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 us at 1-844-892-8578

Visit nutrastimhair.com

for more information about hair thinning, visit

nutrastimhair.com/women-education/

Section 53414-9

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

Section 55105-1

To regrow hair on the scalp.

Section 55106-9

Minoxidil 2% w/v

Directions
  • Apply 1 ml, 2 times daily directly with the dropper 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
  • Before use see hair loss pictures on side of this box.
  • Keep the box, 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 minoxidil topical solution was 2% 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 20° to 25° C (68° to 77° F).

Keep tightly closed.


Structured Label Content

Warnings and Precautions (34071-1)
  • For external use only.
  • For use by women 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. (1-800-222-1222).

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 with 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)
  • Your degree 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 child birth.
  • 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 us at 1-844-892-8578

Visit nutrastimhair.com

for more information about hair thinning, visit

nutrastimhair.com/women-education/

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

To regrow hair on the scalp.

Section 55106-9 (55106-9)

Minoxidil 2% w/v

Directions
  • Apply 1 ml, 2 times daily directly with the dropper 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)
  • Before use see hair loss pictures on side of this box.
  • Keep the box, 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 minoxidil topical solution was 2% 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 20° to 25° C (68° to 77° F).

Keep tightly closed.


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