5% Minoxidil Hair Regrowth Spray With Biotin

5% Minoxidil Hair Regrowth Spray With Biotin
SPL v3
SPL
SPL Set ID 21341809-15ef-a694-e063-6394a90a5720
Route
TOPICAL
Published
Effective Date 2024-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Biotin (0.5 g) Minoxidil (5 g)
Inactive Ingredients
Water Alcohol Castor Oil Panthenol Butylene Glycol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-03

Description

5% Minoxidil Hair Regrowth SPRAY With Biotin


Medication Information

Warnings and Precautions

For external use only.For use by rnen only.

Keep out of reach of children.

Indications and Usage

use to regrow hair of scalp and beard

Dosage and Administration

Apply 3-4 pumps of Extra Strength 5% Minoxidil Spray directly onto scalp on the hair loss area.

Use fingertips to massage the spray into skin/hair for 1 minute, then wash hands thoroughly.

Used twice daily on clean ,dry hair for best results.

Description

5% Minoxidil Hair Regrowth SPRAY With Biotin

Section 42229-5

5% Minoxidil Hair Regrowth SPRAY With Biotin

Section 44425-7

Before use, read all information on carton and enclosed leaflet.

Store at controlled room temperature 10° to 25°c (50° to 77°F).

Do not incinerate container, o not expose to heat or store at temperature above 104"F (40"C)

Section 50565-1

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

Section 50566-9

If scalp irritation or redness occurs.

if you get unwanted facial hair growth.

if you do not see hair regrowith in 4 months.

if sudden, unexplained weight gain occurs.

if you have chest pain, rapid heartbeat, faintness, or dizziness occurs.

if your hands or feet swell.

Section 50567-7

Do not apply on other parts of the body.

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

The amount of hair regrowth is different for each person.This product wilt hot work for all men.

Section 50570-1

You are a worran.

You have no family history of hair loss.

Your hair loss is sudden andjor 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.

Section 51727-6

Castor oil

Alcohol

Glycerin

Butylene glycol

Panthenol

Water

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 scalp and beard

Dosage and Administration (34068-7)

Apply 3-4 pumps of Extra Strength 5% Minoxidil Spray directly onto scalp on the hair loss area.

Use fingertips to massage the spray into skin/hair for 1 minute, then wash hands thoroughly.

Used twice daily on clean ,dry hair for best results.

Warnings and Precautions (34071-1)

For external use only.For use by rnen only.

Keep out of reach of children.

Section 42229-5 (42229-5)

5% Minoxidil Hair Regrowth SPRAY With Biotin

Section 44425-7 (44425-7)

Before use, read all information on carton and enclosed leaflet.

Store at controlled room temperature 10° to 25°c (50° to 77°F).

Do not incinerate container, o not expose to heat or store at temperature above 104"F (40"C)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

If scalp irritation or redness occurs.

if you get unwanted facial hair growth.

if you do not see hair regrowith in 4 months.

if sudden, unexplained weight gain occurs.

if you have chest pain, rapid heartbeat, faintness, or dizziness occurs.

if your hands or feet swell.

Section 50567-7 (50567-7)

Do not apply on other parts of the body.

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

The amount of hair regrowth is different for each person.This product wilt hot work for all men.

Section 50570-1 (50570-1)

You are a worran.

You have no family history of hair loss.

Your hair loss is sudden andjor 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.

Section 51727-6 (51727-6)

Castor oil

Alcohol

Glycerin

Butylene glycol

Panthenol

Water

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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