83717-004

83717-004
SPL v1
SPL
SPL Set ID 20687945-c5ce-ff4f-e063-6394a90a0fd8
Route
CUTANEOUS
Published
Effective Date 2024-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Rosemary Oil Ginger Asian Ginseng Castor Oil Propylene Glycol Glycerin Polyoxyl 40 Hydrogenated Castor Oil Biotin Xanthan Gum Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-08-24

Description

Minoxidil 5%

Purpose

Hair Regrowth Treatment


Medication Information

Purpose

Hair Regrowth Treatment

Description

Minoxidil 5%

Use

to regrow hair on the top of the scalp

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 51945-4

Section 55106-9

Minoxidil 5%

Warnings

• For external use only

• Keep away from fire and flame

• Avoid contact with eyes

Directions

Apply 1ml(5 Sprays) twice a day.Once in the morning and another time in the evening before bed.

Spray directly on top of the scalp in the area to be treated.

Discontinuing use may result in hair loss.

Do Not Use

• You have no family history of hair loss. 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 it onbabies and children.Scalp is red, inflamed, infected, irritated or painful.

• You use other medicines on the scalp.

Inactive Ingredients

WATER, PROPYLENE GLYCOL, GLYCERIN, ZINGIBER OFFICINALE(GINGER)ROOT EXTRACT, PEG-40 HYDROGENATED CASTOR OIL, PANAX GINSENG EXTRACT, BIOTIN, XANTHAN GUM, RICINUS COMMUNIS(CASTOR)OIL, ROSMARINUS OFFICINALIS(ROSEMARY)LEAF OIL.

Stop Use and See A Doctor

• If scalp irritation or redness occurs.

• If you get unwanted facial hair growth.

• If you do not see hair regrowth in 4 months.

• If sudden, unexplained weight gain occurs.


Structured Label Content

Use

to regrow hair on the top of the scalp

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Minoxidil 5%

Purpose

Hair Regrowth Treatment

Warnings

• For external use only

• Keep away from fire and flame

• Avoid contact with eyes

Directions

Apply 1ml(5 Sprays) twice a day.Once in the morning and another time in the evening before bed.

Spray directly on top of the scalp in the area to be treated.

Discontinuing use may result in hair loss.

Do Not Use (Do not use)

• You have no family history of hair loss. 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 it onbabies and children.Scalp is red, inflamed, infected, irritated or painful.

• You use other medicines on the scalp.

Inactive Ingredients (Inactive ingredients)

WATER, PROPYLENE GLYCOL, GLYCERIN, ZINGIBER OFFICINALE(GINGER)ROOT EXTRACT, PEG-40 HYDROGENATED CASTOR OIL, PANAX GINSENG EXTRACT, BIOTIN, XANTHAN GUM, RICINUS COMMUNIS(CASTOR)OIL, ROSMARINUS OFFICINALIS(ROSEMARY)LEAF OIL.

Stop Use and See A Doctor (STOP USE AND SEE A DOCTOR)

• If scalp irritation or redness occurs.

• If you get unwanted facial hair growth.

• If you do not see hair regrowth in 4 months.

• If sudden, unexplained weight gain occurs.


Advanced Ingredient Data


Raw Label Data

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