81653-013 Update

81653-013 Update
SPL v3
SPL
SPL Set ID 0d8beb7c-48be-54de-e063-6394a90a4149
Route
TOPICAL
Published
Effective Date 2023-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-12-04

Description

Minoxidil 5% w/v

Purpose

Hair Growth Serum for people


Medication Information

Purpose

Hair Growth Serum for people

Description

Minoxidil 5% w/v

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Label

Warnings

For external use only

Flammable:
Keep away from fire or flame

Directions

■ Apply 1 ml twice a day directly onto the scalp in the hair loss area

■ massage into scalp with fingers, then wash hands well

■ 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

Ingredients

Reynoutria Multiflora Whole

Angelica Sinensis Whole

Biotin

Platycladus Orientalis Leaf

Asian Ginseng

Carthamus Tinctorius Whole

Dictamnus Dasycarpus Root Bark

Ligustrum Lucidum Fruit

Alcohol

Ligusticum Sinense Subsp. Chuanxiong Root

Glycyrrhiza Uralensis Whole

Capsaicin

MARINE COLLAGEN SOLUBLE

Ginger

Arctium Lappa Whole

Do Not Use If

■ our amount of hair loss is different than that shown the side of this carton or your hair loss is on the front of the scalp. Hair Growth Serum is not intended for frontal baldness or receding hairline

■ you have no family history of hair loss

■ your hair loss is sudden and/or patch

■ 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, infected, irritated, or painful

■ you use other medicines on the scalp

Active Ingredient

Minoxidil 5% w/v

Other Information

keep the carton. t contains important information.

store at 20° to 25°C (68°to 77°F). Keep tightly closed.

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 people, 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 people

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 top of the scalp (vertex only, see pictures on side of carton)

Label

Purpose

Hair Growth Serum for people

Warnings

For external use only

Flammable:
Keep away from fire or flame

Directions

■ Apply 1 ml twice a day directly onto the scalp in the hair loss area

■ massage into scalp with fingers, then wash hands well

■ 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

Ingredients

Reynoutria Multiflora Whole

Angelica Sinensis Whole

Biotin

Platycladus Orientalis Leaf

Asian Ginseng

Carthamus Tinctorius Whole

Dictamnus Dasycarpus Root Bark

Ligustrum Lucidum Fruit

Alcohol

Ligusticum Sinense Subsp. Chuanxiong Root

Glycyrrhiza Uralensis Whole

Capsaicin

MARINE COLLAGEN SOLUBLE

Ginger

Arctium Lappa Whole

Do Not Use If (Do not use if)

■ our amount of hair loss is different than that shown the side of this carton or your hair loss is on the front of the scalp. Hair Growth Serum is not intended for frontal baldness or receding hairline

■ you have no family history of hair loss

■ your hair loss is sudden and/or patch

■ 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, infected, irritated, or painful

■ you use other medicines on the scalp

Active Ingredient (Active ingredient)

Minoxidil 5% w/v

Other Information (Other information)

keep the carton. t contains important information.

store at 20° to 25°C (68°to 77°F). Keep tightly closed.

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 people, 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 people

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

All Sections (JSON)