​81653-005 Update

​81653-005 Update
SPL v3
SPL
SPL Set ID eb87ff2d-7708-4c4d-e053-2a95a90ac72b
Route
TOPICAL
Published
Effective Date 2022-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Alcohol Ligusticum Sinense Subsp. Chuanxiong Root Capsaicin Dictamnus Dasycarpus Root Platycladus Orientalis Whole Ligustrum Lucidum Fruit Glycyrrhiza Uralensis Whole Reynoutria Multiflora Root Angelica Sinensis Whole Biotin Water Carthamus Tinctorius Whole Asian Ginseng

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-10-20

Description

Minoxidil 5% w/v


Medication Information

Warnings and Precautions

For external use only.

Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

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

Indications and Usage

Remixidil Foam is for some people who have a general thinning of hair on the top of the scalp (vertex only, as shownbelow). Not intended for frontal baldness or a receding hairline. Remixidil Foam has been shown to regrow hair in some people with the following degrees of thinning hair or hair loss.

Dosage and Administration

apply half a capful 2 times a day to the scalp in the hair loss area

massage into scalp with fingers then wash hands well

see enclosed booklet for complete directions on how to use

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 43685-7

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 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, youmay 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 and women

Section 44425-7

store at controlled room temperature 20° to 25C (68° to 77°F)

contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store attemperatures above 120°F(49°c)

lngredients

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 or redness occursunwanted facial hair growth occurs

you do not see hair regrowth in 4 months

Ask a doctor before use if you have heart disease

Section 55105-1

Use to regrow hair on the top of the scalp (vertex only)

Section 55106-9

Minoxidil 5% w/v

Section 60561-8

before use, read all information on carton and enclosed leafletkeep the package, It contains important information

Lnactive Ingredients

Water, Polygonum multiflorum Thunb, Angelica Sinensis, Vitamin H.(Biotin), Cacumen Platycladi Orientalis, Ginseng Extract, Carthamus tinctorius L. Extract, Cortex Dictamni , Fructus Ligustri Lucidi Extract , Alcohol, Ligusticum Chuanxiong Hort Extract, Glycyrrhiza uralensis Fisch Extract, Capsaicin

Keep Out of Reach of Children

Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center right away.

Hair Regrowth Treatment for Men

Hair Regrowth Treatment for Women


Structured Label Content

Indications and Usage (34067-9)

Remixidil Foam is for some people who have a general thinning of hair on the top of the scalp (vertex only, as shownbelow). Not intended for frontal baldness or a receding hairline. Remixidil Foam has been shown to regrow hair in some people with the following degrees of thinning hair or hair loss.

Dosage and Administration (34068-7)

apply half a capful 2 times a day to the scalp in the hair loss area

massage into scalp with fingers then wash hands well

see enclosed booklet for complete directions on how to use

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.

Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

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

Section 43685-7 (43685-7)

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 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, youmay 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 and women

Section 44425-7 (44425-7)

store at controlled room temperature 20° to 25C (68° to 77°F)

contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store attemperatures above 120°F(49°c)

lngredients

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 or redness occursunwanted facial hair growth occurs

you do not see hair regrowth in 4 months

Ask a doctor before use if you have heart disease

Section 55105-1 (55105-1)

Use to regrow hair on the top of the scalp (vertex only)

Section 55106-9 (55106-9)

Minoxidil 5% w/v

Section 60561-8 (60561-8)

before use, read all information on carton and enclosed leafletkeep the package, It contains important information

Lnactive Ingredients (lnactive ingredients)

Water, Polygonum multiflorum Thunb, Angelica Sinensis, Vitamin H.(Biotin), Cacumen Platycladi Orientalis, Ginseng Extract, Carthamus tinctorius L. Extract, Cortex Dictamni , Fructus Ligustri Lucidi Extract , Alcohol, Ligusticum Chuanxiong Hort Extract, Glycyrrhiza uralensis Fisch Extract, Capsaicin

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center right away.

Hair Regrowth Treatment for Men (Hair regrowth treatment for Men)

Hair Regrowth Treatment for Women (Hair regrowth treatment for Women)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)