85304-020 Rdvhdlw 5% Minoxidil Hair Growth Foam With Biotin

85304-020 Rdvhdlw 5% Minoxidil Hair Growth Foam With Biotin
SPL v1
SPL
SPL Set ID 41ba1c1a-2193-466f-e063-6294a90a18f9
Route
TOPICAL
Published
Effective Date 2025-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Biotin (0.5 g) Minoxidil (5 g)
Inactive Ingredients
Water Edetate Disodium Citric Acid Glycerin Stearyl Alcohol Butane Cetyl Alcohol Isobutane Lactic Acid Alcohol Polysorbate 60

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-22

Description

Minoxidil 5% Biotin 0.5%


Medication Information

Warnings and Precautions

Flammable:keep away from fire or flame.

Keep out of reach of children.

For external use only.

Indications and Usage

Use to regrow hair of the scalp

Dosage and Administration



1.Hold the botle upside down and genly press the valve to dispense foam onto your hand or a cold surface, approximately half a capful in size.

2.Massage the foam into your scalp with your fingers, parting your hair into rows to ensure even application to areas of thinning hair. Finally, wash your hands thoroughly.

3.Use Twice Daily and enjoy thicker, fuller hair growth in as little as 3 to 6 months.

Description

Minoxidil 5% Biotin 0.5%

Section 50565-1

Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center

(1-800-222-1222) right away.

Section 50566-9



Chest pain, rapid heartbeat, faintness, or dizziness occurs.

Sudden. unexplained weight gain occurs.

lf unwanted facial hair growth occurs.

If you do not see hair regrowth in 6 months.

Section 50567-7



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 andlor texture.

It takes time to regrow hair. Results may occur at 3 months with twice a day usage. For some men, you may need to use this product for at least 6 months before you see results. The amount of hair regrowth is different for each person.

Avoid contact with eyes. In case of accidental contact, rinse eves with a large amount of cool tap water.

Section 50570-1

Your hair loss is sudden and'or patchy.

Your hair loss is associated with childbirth.

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.

Section 51727-6

cetyl alcohol

citric acid

glycerin

isobutane

lactic acid

polysorbate 60

purified water

SD alcohol 40-B

stearyl alcohol

butane

edetate disodium

Section 51945-4

Section 55105-1

Hair Regrowth Treatment

Section 55106-9

Minoxidil 5%

Biotin 0.5%


Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair of the scalp

Dosage and Administration (34068-7)



1.Hold the botle upside down and genly press the valve to dispense foam onto your hand or a cold surface, approximately half a capful in size.

2.Massage the foam into your scalp with your fingers, parting your hair into rows to ensure even application to areas of thinning hair. Finally, wash your hands thoroughly.

3.Use Twice Daily and enjoy thicker, fuller hair growth in as little as 3 to 6 months.

Warnings and Precautions (34071-1)

Flammable:keep away from fire or flame.

Keep out of reach of children.

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center

(1-800-222-1222) right away.

Section 50566-9 (50566-9)



Chest pain, rapid heartbeat, faintness, or dizziness occurs.

Sudden. unexplained weight gain occurs.

lf unwanted facial hair growth occurs.

If you do not see hair regrowth in 6 months.

Section 50567-7 (50567-7)



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 andlor texture.

It takes time to regrow hair. Results may occur at 3 months with twice a day usage. For some men, you may need to use this product for at least 6 months before you see results. The amount of hair regrowth is different for each person.

Avoid contact with eyes. In case of accidental contact, rinse eves with a large amount of cool tap water.

Section 50570-1 (50570-1)

Your hair loss is sudden and'or patchy.

Your hair loss is associated with childbirth.

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.

Section 51727-6 (51727-6)

cetyl alcohol

citric acid

glycerin

isobutane

lactic acid

polysorbate 60

purified water

SD alcohol 40-B

stearyl alcohol

butane

edetate disodium

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair Regrowth Treatment

Section 55106-9 (55106-9)

Minoxidil 5%

Biotin 0.5%


Advanced Ingredient Data


Raw Label Data

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