Rootly Extra Strength Hair Regrowth Treatment For Men

Rootly Extra Strength Hair Regrowth Treatment For Men
SPL v2
SPL
SPL Set ID ca58449e-6641-4225-e053-2995a90a5a41
Route
TOPICAL
Published
Effective Date 2021-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Propylene Glycol Water Isopropyl Alcohol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-08-24

Description

Minoxidil 5% w/v


Medication Information

Warnings and Precautions

For external use only.

Flammable: Keep away from fire or flame.

Description

Minoxidil 5% w/v

Use

to regrow hair on the top of the scalp

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if

  • 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

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. For some men, you may need to use this product 2 times a day 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 men.
Section 50569-3

Ask a doctor before use if you have heart disease

Section 50570-1

Do not use if

  • You are a woman
  • 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

lcohol, Propylene Glycol, Purified Water

Section 51945-4

Section 53413-1

Questions or comments

Call toll-free 1-800-681-0241 or visit hellorootly.com

Section 53414-9

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

Section 55105-1

Hair regrowth treatment for men

Section 55106-9

Minoxidil 5% w/v

Directions

• 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.

• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men

• in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

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


Structured Label Content

Use (USE)

to regrow hair on the top of the 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 doctor if

  • 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)

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. For some men, you may need to use this product 2 times a day 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 men.
Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 50570-1 (50570-1)

Do not use if

  • You are a woman
  • 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)

lcohol, Propylene Glycol, Purified Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments

Call toll-free 1-800-681-0241 or visit hellorootly.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Hair regrowth treatment for men

Section 55106-9 (55106-9)

Minoxidil 5% w/v

Directions (DIRECTIONS)

• 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.

• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men

• in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

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


Advanced Ingredient Data


Raw Label Data

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