Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Form with Biotin

Manufacturer
GAINXTRA LLC
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:16:18

Label at a glance#

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

Dosage and administration

apply half a capful 2 times a day to the scalp in the hair loss area massage into scalp with fingers, then wash hands. using more or more often will not improve results. 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/w

(without propellant)

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 Form 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 half a capful 2 times a day to the scalp in the hair loss area
  • massage into scalp with fingers, then wash hands.
  • using more or more often will not improve results.
  • 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, Propylene Glycol, Hyaluronic Acid, Cocamidopropyl Betadine, Keratine, Amino Acids, Tocopherol (Vitamin E), Glycerin, Xanthan Gum, Capryloyl Silk Amino Acids, Allantoin, Aloe Barbadensis Leaf Extract, Citrus Paradisi (Grapefruit) Seed Extract, Polygonum Cuspidatum Extract, Biotin, Ethylhexylglycerin.

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
645146minoxidil 5 % Topical FoamPSN1
645146minoxidil 50 MG/ML Topical FoamSCD1
645146minoxidil 5 % Topical FoamSY1

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
QR code linkQR Codegainxtra.com/hair/foamcarton.jpg, leaflet.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85929-101-18Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Form with Biotin3 in 1 BOXAEROSOL, FOAM31
85929-101-18Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Form with Biotin60 g in 1 CANAEROSOL, FOAM601

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85929-10185929-101-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
43368b92-732b-68c6-e063-6294a90acd880126ea41-2cdc-4a6c-af5f-d036ef3679e52025-11-10WarningsExact identifier
spl id: 43368b92-732b-68c6-e063-6294a90acd88
spl set id: 0126ea41-2cdc-4a6c-af5f-d036ef3679e5

Reported adverse events (FAERS/openFDA)#

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