85092-001

85092-001
SPL v1
SPL
SPL Set ID 2aca0406-52e9-5222-e063-6294a90abbb5
Route
TOPICAL
Published
Effective Date 2025-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Polysorbate 20 Peg-40 Hydrogenated Castor Oil Platycladus Orientalis Leaf Edetate Disodium Biotin Niacinamide Water Panthenol Azelaic Acid Apigenin Acetyl Tetrapeptide-3 Oleanolic Acid Rosemary Oil Ppg-26-buteth-26 Iodopropynyl Butylcarbamate Caffeine Biotinoyl Tripeptide-1 Butylene Glycol Propylene Glycol Caramel Elaeis Oleifera Seed Oil Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-01-03

Description

Minoxidil 5%

Purpose

Hair Growth


Medication Information

Purpose

Hair Growth

Description

Minoxidil 5%

Uses

Helps hair growth

Warnings

For external use only

Directions

● Spray 1ml(4 sprays) directly on topof the scalp of the hair loss area.(Men:Twice each day/ Women:Once each day)

● Massage into the scalp with your fingers then wash hands thoroughly.

● Using more hair regrowth serum or using the serum more often will not improve your results.

● Continued use is necessary to increase and keep your hair regrowth or hair loss will begin again.

85092 001 01

Do Not Use If

● you have no family history of hair loss.

● your 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.

● your scalp is red, inflamed, infected, irritated or painful

● you use other medicines on the scalp.

Active Ingredient

Minoxidil 5%

Other Information

• Before use, read all information on carton

• Keep the carton. It contains important information.

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

Inactive Ingredient

Water, Glycerin, Propylene Glycol, Panthenol, Niacinamide, Solubilisant Lri, Iodopropynyl Butylcarbamate, Butylene Glycol, Caramel, Polysorbate 20, Caffeine, Biota Orientalis Leaf Extract, Biotin, Azelaic Acid, Peg-40 Hydrogenated Castor Oil, Aroma, Disodium Edta, Apigenin, Acetyl Tetrapeptide-3, Oleanolic Acid, Biotinyl Tripeptide-1,Rosemary Oil,Batana Oil

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 accur at 2 months, with twice a day usage. For some men, 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 men.

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Helps hair growth

Purpose

Hair Growth

Warnings

For external use only

Directions

● Spray 1ml(4 sprays) directly on topof the scalp of the hair loss area.(Men:Twice each day/ Women:Once each day)

● Massage into the scalp with your fingers then wash hands thoroughly.

● Using more hair regrowth serum or using the serum more often will not improve your results.

● Continued use is necessary to increase and keep your hair regrowth or hair loss will begin again.

85092 001 01 (85092-001-01)

Do Not Use If (Do not use if)

● you have no family history of hair loss.

● your 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.

● your scalp is red, inflamed, infected, irritated or painful

● you use other medicines on the scalp.

Active Ingredient (Active ingredient)

Minoxidil 5%

Other Information (Other information)

• Before use, read all information on carton

• Keep the carton. It contains important information.

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

Inactive Ingredient

Water, Glycerin, Propylene Glycol, Panthenol, Niacinamide, Solubilisant Lri, Iodopropynyl Butylcarbamate, Butylene Glycol, Caramel, Polysorbate 20, Caffeine, Biota Orientalis Leaf Extract, Biotin, Azelaic Acid, Peg-40 Hydrogenated Castor Oil, Aroma, Disodium Edta, Apigenin, Acetyl Tetrapeptide-3, Oleanolic Acid, Biotinyl Tripeptide-1,Rosemary Oil,Batana Oil

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 accur at 2 months, with twice a day usage. For some men, 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 men.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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