​81653-003 Update

​81653-003 Update
SPL v4
SPL
SPL Set ID dec7249c-e1f9-b5eb-e053-2995a90acf37
Route
TOPICAL
Published
Effective Date 2022-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Water Safflower Capsaicin Ligusticum Sinense Subsp. Chuanxiong Root Ligustrum Lucidum Fruit Angelica Sinensis Root Reynoutria Multiflora Root Biotin Pork Collagen Panax Ginseng Fruit Frangula Alnus Bark Glycyrrhiza Uralensis Root Platycladus Orientalis Whole

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-03-23

Description

Minoxidil 5%


Medication Information

Warnings and Precautions

For adult external use only. Flammable. Keep away fromheat or flame.

Do not use

·Pregnant women and children.

·on open skin wounds

Indications and Usage

for hair loss

Apply half a capful once daily to directly to 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

Dosage and Administration

THIS PACKAGE CONTAINS. One 60g (2.11 fl oz) cans of Foam (one month supply)

Apply half a capful once daily to directly to the scalp in the hair loss area massage into scalp with fingers

Description

Minoxidil 5%

Section 43685-7

When using this product keep out of eyes, ears, andmouth. In case of contact with eyes, rinse eyes thoroughlywith water.

Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition.

Section 50566-9

Do not use

- Pregnant women and children.

- on open skin wounds

when using this product

keep out of eyes,ears, and mouth. ln case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rashoccurs.These may be signs of a serious condition.

Keep out of reach of children.

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

Section 51945-4

Section 55105-1

STRONGER THICKER LONGER HAIR

REDUCE HAIR LOSS

RESTORE THINNING HAIR

The Foam is for somepeople who have a general thinning of hair on the top of the scalp(vertex only, asshown below). Not intendedfor frontal baldness or areceding hairline. The Foamhas been shown to regrowhair in some people with thefollowing degrees of thinninghair or hair loss.



lf you have more hair loss or hair loss in a place different than shown above, Foam may not work.

Section 60562-6

USING THE PRODUCT

To open container.

The foam may begin to melt right away on contact with your

warm skin. If your fingers arewarm, rinse them in cold water first.(Be sure to dry them thoroughly before handing thefoam.)

Press nozzle to dispense the topical foam product onto your fingers. The total amount of foam applied should not exceed half a capful.

Using your fingers, spread the foam over the hair loss area

and gently massage into scalp and then wash your hands well. After each use, dose the container to make child resistant by snapping the cap back on to the can.

Active Ingredient

Minoxidil 5%

Other Information

Store at Controlled Room Temperature 20 °C to25 °C(68°Fto 77°F)

Contents under pressure.Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F(49 °C).

Don't hold straight upside down

Lnactive Ingredients

Water, Vitamin H (Biotin), Pork Collagen. Panax Ginseng Berry Extract, Carthamus Tinctorius (Safflower) Flower Extract, Frangula Alnus Bark Extract, Ligustrum Lucidum Fruit Extract, Ligusticum Chuanxiong Root Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Angelica Sinensis Root Extract, Platycladus Orientalis, Polygonum Multiflorum Root 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.


Structured Label Content

Indications and Usage (34067-9)

for hair loss

Apply half a capful once daily to directly to 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

Dosage and Administration (34068-7)

THIS PACKAGE CONTAINS. One 60g (2.11 fl oz) cans of Foam (one month supply)

Apply half a capful once daily to directly to the scalp in the hair loss area massage into scalp with fingers

Warnings and Precautions (34071-1)

For adult external use only. Flammable. Keep away fromheat or flame.

Do not use

·Pregnant women and children.

·on open skin wounds

Section 43685-7 (43685-7)

When using this product keep out of eyes, ears, andmouth. In case of contact with eyes, rinse eyes thoroughlywith water.

Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition.

Section 50566-9 (50566-9)

Do not use

- Pregnant women and children.

- on open skin wounds

when using this product

keep out of eyes,ears, and mouth. ln case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rashoccurs.These may be signs of a serious condition.

Keep out of reach of children.

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

STRONGER THICKER LONGER HAIR

REDUCE HAIR LOSS

RESTORE THINNING HAIR

The Foam is for somepeople who have a general thinning of hair on the top of the scalp(vertex only, asshown below). Not intendedfor frontal baldness or areceding hairline. The Foamhas been shown to regrowhair in some people with thefollowing degrees of thinninghair or hair loss.



lf you have more hair loss or hair loss in a place different than shown above, Foam may not work.

Section 60562-6 (60562-6)

USING THE PRODUCT

To open container.

The foam may begin to melt right away on contact with your

warm skin. If your fingers arewarm, rinse them in cold water first.(Be sure to dry them thoroughly before handing thefoam.)

Press nozzle to dispense the topical foam product onto your fingers. The total amount of foam applied should not exceed half a capful.

Using your fingers, spread the foam over the hair loss area

and gently massage into scalp and then wash your hands well. After each use, dose the container to make child resistant by snapping the cap back on to the can.

Active Ingredient (Active ingredient)

Minoxidil 5%

Other Information (other information)

Store at Controlled Room Temperature 20 °C to25 °C(68°Fto 77°F)

Contents under pressure.Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F(49 °C).

Don't hold straight upside down

Lnactive Ingredients (lnactive ingredients)

Water, Vitamin H (Biotin), Pork Collagen. Panax Ginseng Berry Extract, Carthamus Tinctorius (Safflower) Flower Extract, Frangula Alnus Bark Extract, Ligustrum Lucidum Fruit Extract, Ligusticum Chuanxiong Root Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Angelica Sinensis Root Extract, Platycladus Orientalis, Polygonum Multiflorum Root 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.


Advanced Ingredient Data


Raw Label Data

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