Minoxidil

Manufacturer
GAINXTRA LLC
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:43:01

Label at a glance#

ProductGainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin
Active ingredientMINOXIDIL
Label structure15 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Minoxidil  5% W/V

PURPOSE

OTC - PURPOSE SECTION

Hair regrowth treatment for men and women

USE

INDICATIONS & USAGE SECTION

To regrow hair the scalp

WARNINGS

WARNINGS SECTION

For external use only.

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

Do not use if:

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have heart disease.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

OTHER SAFETY 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 INGREDIENT SECTION

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.

Questions?

OTC - QUESTIONS SECTION

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

Manufactured for and distributed by:

Gainxtra LLC

3162 Martin Road

Commerce Township, MI 48390

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

22

33

Save this leaflet for future reference.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1537948minoxidil 5 % Topical SprayPSN1
1537948minoxidil 50 MG/ML Topical SpraySCD1
1537948minoxidil 5 % Topical SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385929100018GTIN-13: 0385929100018
EAN-13: 0385929100018
GTIN-12: 385929100018
UPC-A: 385929100018
GTIN storage (14 digits): 00385929100018
carton.jpg
QR code linkQR Codegainxtra.com/hair/spraycarton.jpg
Data codeQR Codegainxtra.com/hair/sprayleaflet.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85929-100-01Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin60 mL in 1 BOTTLE, SPRAYSPRAY601
85929-100-01Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin1 in 1 BOXSPRAY11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85929-10085929-100-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
42467407-870a-ca85-e063-6294a90ad86bc9b57d68-9aba-471b-b07a-9ba41b38c7622025-10-29WarningsExact identifier
spl id: 42467407-870a-ca85-e063-6294a90ad86b
spl set id: c9b57d68-9aba-471b-b07a-9ba41b38c762

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.