Tomum Hair Growth Treatment For Men 5% Minoxidil, Unscented

Tomum Hair Growth Treatment For Men 5% Minoxidil, Unscented
SPL v1
SPL
SPL Set ID 4c0582a3-f2be-4e53-a174-12269f7ddad0
Route
TOPICAL
Published
Effective Date 2024-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-09-27

Description

Minoxidil 5%w/v

Purpose

Hair regrowth treatment for men


Medication Information

Purpose

Hair regrowth treatment for men

Description

Minoxidil 5%w/v

Use

to regrow hair on the scalp

Section 53414-9

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

Warnings

For external use only. For use by men only.

Flammable:Keep away from fire or flame

Drug Facts

Directions
  • prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
  • apply one mL with spray (6 sprays) 2 times a daydirectly 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
Do Not Use If:
  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • 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, irritated or painful

  • you use other medicines on the scalp

Active Ingredient

Minoxidil 5%w/v

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 18-45 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 20° to 25°C (68° to 77°F).

Package Labeling:

Inactive Ingredients:

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments?

 - Call your health professional or contact us at

[email protected]

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 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 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 all men.
Stop Use and Ask A 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

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have

heart disease


Structured Label Content

Use

to regrow hair on the scalp

Section 53414-9 (53414-9)

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

Purpose

Hair regrowth treatment for men

Warnings

For external use only. For use by men only.

Flammable:Keep away from fire or flame

Drug Facts (DRUG FACTS)

Directions
  • prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
  • apply one mL with spray (6 sprays) 2 times a daydirectly 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
Do Not Use If: (Do not use if:)
  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • 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, irritated or painful

  • you use other medicines on the scalp

Active Ingredient (Active ingredient)

Minoxidil 5%w/v

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 18-45 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 20° to 25°C (68° to 77°F).

Package Labeling:

Inactive Ingredients: (Inactive ingredients:)

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments? (Questions or comments?)

 - Call your health professional or contact us at

[email protected]

When Using This Product (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 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 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 all men.
Stop Use and Ask A Doctor If (Stop use and ask a 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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease


Advanced Ingredient Data


Raw Label Data

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