Gainxtra Hair Regrowth Treatment For Men And Women Minoxidil 5% Sprays With Biotin

Gainxtra Hair Regrowth Treatment For Men And Women Minoxidil 5% Sprays With Biotin
SPL v1
SPL
SPL Set ID c9b57d68-9aba-471b-b07a-9ba41b38c762
Route
TOPICAL
Published
Effective Date 2025-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
Water Propylene Glycol Biotin Panthenol Copper Tripeptide-1 Arginine Platycladus Orientalis Leaf Ginger Artemisia Argyi Leaf Artemisia Annua Leaf Gentiana Scabra Root Sophora Flavescens Root Lecithin, Soybean Ethylhexylglycerin Caprylhydroxamic Acid Dipotassium Glycyrrhizate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-07

Description

DRUG FACTS

Purpose

Hair regrowth treatment for men and women


Medication Information

Purpose

Hair regrowth treatment for men and women

Description

DRUG FACTS

Use

To regrow hair the scalp

Section 42229-5

DRUG FACTS

Section 50569-3

Ask a doctor before use if you have heart disease.

Section 51945-4

Save this leaflet for future reference.

Warnings

For external use only.

Extremely Flammable: Avoid Fire, flame, or smoking during and immediately following application.

Directions
  • Apply 5 sprays twice daily directly onto the scalp in the area of hair loss
  • massage into scalp with fingers, then wash hands well
  • continued use is necessary to increase and maintain your hair regrowth or hair loss will begin again
Questions?

Call (1-248-923-5024) or gainxtra.com

Manufactured for and distributed by:

Gainxtra LLC

3162 Martin Road

Commerce Township, MI 48390

Do Not Use If:
  • the amount of hair loss is different the amount that is shown on the carton or your hair loss is on the front of the scalp. 5% Minoxidil Spray is not intended for frontal baldness of receding hairline.
  • you have no family history of hair loss
  • your hair is sudden and/or patchy
  • you do not know the reason for your hair loss
  • you are 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% W/V

Other Information
  • hair growth has been shown in a clinical study of men and women aged 18-49 years who used it for 4 months
  • read all information and the enclosed leaflet before use
  • store at this controlled room temperature 20° to 25°C (68° to 77°F)
  • do not expose to hear or store in temperatures above 120°F (49°C)
  • increasing the dose or frequency of use will not accelerate hair growth
Inactive Ingredients

Purified Water, Dipotassium Glycyrrhizinate, Propylene Glycol, Biotin, Panthenol, Tripeptide-1 Copper, Arginine, Platycladus Orientalis Leaf Extract, Zingiber Officinale Root Extract, Mugwort (Artemisia Argyi) Leaf Extract, Artemisia Annua (Artemisia Annua) Extract, Gentiana (Gentiana Scabra) Root Extract, Sophora Angustifolia (Sophora Angustifolia) Root Extract, Lecithin, Ethylhexylglycerin, Caprylyl Hydroxamic Acid.

When Using This Product
  • do not apply to other body parts
  • 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. Some men and women may need to use this product for up to 4 months before seeing results
  • the amount of hair regrowth is different for each person. This product will not work for all men and women
Stop Use and Ask A Doctor If
  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • sudden, unexplained weight gain occurs
  • your hands or feet swell
  • scalp irritation or redness occurs
  • unwanted facial hair growth occurs
  • you do not see hair regrowth within 4 months
May Be Harmful If Used When Pregnant Or Breast Feeding. Keep Out of Reach of Children.

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


Structured Label Content

Use (USE)

To regrow hair the scalp

Section 42229-5 (42229-5)

DRUG FACTS

Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease.

Section 51945-4 (51945-4)

Save this leaflet for future reference.

Purpose (PURPOSE)

Hair regrowth treatment for men and women

Warnings (WARNINGS)

For external use only.

Extremely Flammable: Avoid Fire, flame, or smoking during and immediately following application.

Directions
  • Apply 5 sprays twice daily directly onto the scalp in the area of hair loss
  • massage into scalp with fingers, then wash hands well
  • continued use is necessary to increase and maintain your hair regrowth or hair loss will begin again
Questions?

Call (1-248-923-5024) or gainxtra.com

Manufactured for and distributed by:

Gainxtra LLC

3162 Martin Road

Commerce Township, MI 48390

Do Not Use If: (Do not use if:)
  • the amount of hair loss is different the amount that is shown on the carton or your hair loss is on the front of the scalp. 5% Minoxidil Spray is not intended for frontal baldness of receding hairline.
  • you have no family history of hair loss
  • your hair is sudden and/or patchy
  • you do not know the reason for your hair loss
  • you are 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% W/V

Other Information (Other information)
  • hair growth has been shown in a clinical study of men and women aged 18-49 years who used it for 4 months
  • read all information and the enclosed leaflet before use
  • store at this controlled room temperature 20° to 25°C (68° to 77°F)
  • do not expose to hear or store in temperatures above 120°F (49°C)
  • increasing the dose or frequency of use will not accelerate hair growth
Inactive Ingredients (Inactive ingredients)

Purified Water, Dipotassium Glycyrrhizinate, Propylene Glycol, Biotin, Panthenol, Tripeptide-1 Copper, Arginine, Platycladus Orientalis Leaf Extract, Zingiber Officinale Root Extract, Mugwort (Artemisia Argyi) Leaf Extract, Artemisia Annua (Artemisia Annua) Extract, Gentiana (Gentiana Scabra) Root Extract, Sophora Angustifolia (Sophora Angustifolia) Root Extract, Lecithin, Ethylhexylglycerin, Caprylyl Hydroxamic Acid.

When Using This Product (When using this product)
  • do not apply to other body parts
  • 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. Some men and women may need to use this product for up to 4 months before seeing results
  • the amount of hair regrowth is different for each person. This product will not work for all men and women
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • sudden, unexplained weight gain occurs
  • your hands or feet swell
  • scalp irritation or redness occurs
  • unwanted facial hair growth occurs
  • you do not see hair regrowth within 4 months
May Be Harmful If Used When Pregnant Or Breast Feeding. Keep Out of Reach of Children. (May be harmful if used when pregnant or breast-feeding. Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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