Keranique Hair Regrowth Treatment For Women- Minoxidil 2% Spray

Keranique Hair Regrowth Treatment For Women- Minoxidil 2% Spray
SPL v1
SPL
SPL Set ID e8918aa5-6c0e-5f77-e053-2995a90acddc
Route
TOPICAL
Published
Effective Date 2022-09-13
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 2022-09-13

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 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 everyone.
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 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 1mL 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 the side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep the carton. It contains important 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)

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 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 everyone.
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 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 1mL 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 the side of this carton
  • Before use, read all information on carton and enclosed leaflet
  • Keep the carton. It contains important 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)

Advanced Ingredient Data


Raw Label Data

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