​81653-007 Update

​81653-007 Update
SPL v3
SPL
SPL Set ID 085de93f-dae3-9964-e063-6394a90a5853
Route
TOPICAL
Published
Effective Date 2023-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 mg)
Inactive Ingredients
Pumpkin Seed Oil Niacinamide Peppermint Oil Cocamidopropyl Betaine Allantoin Vitis Vinifera Seed Green Tea Leaf Tea Tree Oil Hyaluronic Acid Caffeine Urtica Dioica Jojoba Oil Xanthan Gum Reynoutria Japonica Leaf Saw Palmetto Rosemary Oil Ethylhexylglycerin Propylene Glycol Water Hair Keratin Amino Acids .alpha.-tocopherol Glycerin Glyoxyloyl Carbocysteine Aloe Vera Leaf Biotin Argan Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-10-23

Description

Minoxidil 5% w/v

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth treatment

Description

Minoxidil 5% w/v

Use

to regrow hair

Section 51945-4

Warnings

For external use only.

Directions

Men: Apply half a capful 2 times a day to the hair loss area.

Women: Apply half a capful 1 time a day to the hair loss area.

Massage to area with fingers, then wash hands well.

Using more and more often will not improve results.

Do Not Use If:

You are a pregnant woman

Your amount of hair loss is different than that shown on the sideof this carton or your hair loss is on the front of the scalp. 5%minoxidil topical foam is not intended for frontal baldness orreceding hairline.

You suffer from metal allergies

You have no family history of hair loss.

You 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.

You scalp is red, inflamed, infected, irritated, or painful.

You use other medicines on the scalp.

Active Ingredient

Minoxidil 5% w/v

Other Information:

Hair growth has been shown in a clinical study of men (mostly

white) aged 18-49 years who used it for 4 months.

Store at controlled room temperature 20° to 25° C (68° to 77° Fcontents under pressure. Do not puncture or incinerate container.Do not expose to heat or store at temperatures above 120°F(49°C)

Inactive Ingredient

Aqua, hyaluronic acid, cocamidopropyl betaine, keratin aminoacids, tocopherol(vitamin E), glycerol, xanthan gum, glyoxyloylallantoin, aloe barbadensis leaf extract, propylene glycol, vitasvinifera seed extract, polygonum cuspidatum extract,ethylhexlglycerin, biotin, argania spinosa kernel oil, simmondsiachinesis (jojoba) seed oil, castor oil, saw palmetto, peppermint oil.rosemary oil, pumpkin seed oil, caffeine, stinging nettle,niancinimide, green tea

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 withtwice a day usage. For some people, you may need to use thisproduct for at least 4 months before you see results.The amount of hair regrowth is different for each person. Thisproduct will not work for all people.

Ask A Doctor Before Use If

you have heart disease

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.

May be harmful if used when pregnant or breast-feeding

Keep Out of Reach of Children.

lf swallowed, get medical help orcontact Poison Control Center right away.


Structured Label Content

Use

to regrow hair

Section 51945-4 (51945-4)

Purpose

Hair regrowth treatment

Warnings

For external use only.

Directions

Men: Apply half a capful 2 times a day to the hair loss area.

Women: Apply half a capful 1 time a day to the hair loss area.

Massage to area with fingers, then wash hands well.

Using more and more often will not improve results.

Do Not Use If: (Do not use if:)

You are a pregnant woman

Your amount of hair loss is different than that shown on the sideof this carton or your hair loss is on the front of the scalp. 5%minoxidil topical foam is not intended for frontal baldness orreceding hairline.

You suffer from metal allergies

You have no family history of hair loss.

You 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.

You scalp is red, inflamed, infected, irritated, or painful.

You use other medicines on the scalp.

Active Ingredient

Minoxidil 5% w/v

Other Information: (Other information:)

Hair growth has been shown in a clinical study of men (mostly

white) aged 18-49 years who used it for 4 months.

Store at controlled room temperature 20° to 25° C (68° to 77° Fcontents under pressure. Do not puncture or incinerate container.Do not expose to heat or store at temperatures above 120°F(49°C)

Inactive Ingredient

Aqua, hyaluronic acid, cocamidopropyl betaine, keratin aminoacids, tocopherol(vitamin E), glycerol, xanthan gum, glyoxyloylallantoin, aloe barbadensis leaf extract, propylene glycol, vitasvinifera seed extract, polygonum cuspidatum extract,ethylhexlglycerin, biotin, argania spinosa kernel oil, simmondsiachinesis (jojoba) seed oil, castor oil, saw palmetto, peppermint oil.rosemary oil, pumpkin seed oil, caffeine, stinging nettle,niancinimide, green tea

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 withtwice a day usage. For some people, you may need to use thisproduct for at least 4 months before you see results.The amount of hair regrowth is different for each person. Thisproduct will not work for all people.

Ask A Doctor Before Use If (Ask a doctor before use if)

you have heart disease

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.

May be harmful if used when pregnant or breast-feeding

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

lf swallowed, get medical help orcontact Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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