Avacor - 5% Minoxidil Topical Solution, Usp

Avacor - 5% Minoxidil Topical Solution, Usp
SPL v2
SPL
SPL Set ID 857b9644-009b-6f66-e053-2991aa0af011
Route
TOPICAL
Published
Effective Date 2019-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2019-04-01

Description

Minoxidil 5% w/v


Medication Information

Warnings and Precautions

For external use only, For use by men only.

Flammable: Keep away from fire or flame

Indications and Usage

Use to regrow hair on the scalp

Dosage and Administration

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

Description

Minoxidil 5% w/v

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 heartbeat, faintness, or dizziness occurs

• sudden, unexplained weight gain occurs

• your hands or feet swell

• scalp irritation of 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 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.

Section 50569-3

Ask a doctor before use if you have heart disease

Section 50570-1
  • 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
Section 51727-6

Inactive Ingredients: 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 5% w/v

Section 59845-8

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

Section 60561-8

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 age 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 USP controlled room temperature 20º to 25ºC (68º to 77ºF).


Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair on the scalp

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only, For use by men 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.

Section 50566-9 (50566-9)

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 of 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 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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 50570-1 (50570-1)
  • 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
Section 51727-6 (51727-6)

Inactive Ingredients: 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 5% w/v

Section 59845-8 (59845-8)

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

Section 60561-8 (60561-8)

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 age 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 USP controlled room temperature 20º to 25ºC (68º to 77ºF).


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)