GETTIK Hair Regrowth Treatment

Manufacturer
GETTIK International LLC
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:41:57

Label at a glance#

ProductGETTIK Hair Regrowth Treatment
Active ingredientMINOXIDIL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5.0% w/v

OTC - PURPOSE SECTION

Hair regrowth treatment for men

INDICATIONS & USAGE SECTION

To regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

WARNINGS SECTION

For external use only

For use by men only

Flammable: Keep away from fire or flame

Do not use if

  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Solution, 5% is not intended for frontal baldness or receding hairline.
  • you have no family history of hair loss
  • your hair loss is sudden and/or 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

Ask a doctor before use if you have heart disease

When using this product

  • do not apply on other parts of the body
  • 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. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
  • the amount of hair regrowth is different for each person. This product will not work for all men.

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 in 4 months

May be harmful if used when pregnant or breast-feeding

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

  • apply one ML 2 times a day directly onto the scalp in the hair loss area
  • using more or more often will not improve results
  • continued use is necessary or hair loss will begin again

OTHER SAFETY INFORMATION

  • see hair loss pictures on side of this carton
  • before use read all information on carton and enclosed leaflet
  • keep the carton, it contains important information
  • hair growth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution 5%
  • in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% provided more hair regrowth than Minoxidil Topical Solutions 2%
  • store at controlled room temperature 20 degree to 25 degree C (68 degree to 77 degree F)

INACTIVE INGREDIENT SECTION

alcohol 30% v/v, propylene glycol 50% v/v, purified water

OTC - QUESTIONS SECTION

Questions: Call your health care professional or Gettik at 1-800-249-8095 or visit our website at gettik.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image1image1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN14
311724minoxidil 50 MG/ML Topical SolutionSCD14
311724minoxidil 3 GM per 60 ML Topical SolutionSY14
311724minoxidil 5 % Topical SolutionSY14
311724minoxidil 5 GM per 100 ML Topical SolutionSY14

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71700-112-052020-08-13C16284748780-19d75b9d0-c715-f424-e053-dadaa90a57ce57dbf5bb-d2b9-4a3a-e053-2a91aa0ae971
71700-112-052020-01-31C16284748780-19d75b9d0-c715-f424-e053-dadaa90a57ce57dbf5bb-d2b9-4a3a-e053-2a91aa0ae971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71700-112-03GETTIK Hair Regrowth Treatment60 mL in 1 BOTTLE, PLASTICLIQUID6014
71700-112-03GETTIK Hair Regrowth Treatment1 in 1 BOXLIQUID114
71700-112-05GETTIK Hair Regrowth Treatment3 in 1 BOXLIQUID314
71700-112-05GETTIK Hair Regrowth Treatment60 mL in 1 BOTTLE, PLASTICLIQUID6014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71700-112GETTIK HAIR REGROWTH TREATMENT (MINOXIDIL 5%) LIQUID [GETTIK INTERNATIONAL LLC]14Legacy NDC, 4 package rows20241212_57dbf5bb-d2b9-4a3a-e053-2a91aa0ae971.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71700-11271700-112-05, 71700-112-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074588-001MINOXIDIL (FOR MEN)MINOXIDIL2%SOLUTION / TOPICAL1996-04-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0584e616aacf4f…
2026-08-18 06:07:402026-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053f01610625f2…
2019-09-15 20:21 UTC2019-09A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074588-001MINOXIDIL (FOR MEN)2%SOLUTION / TOPICAL1996-04-05f41ea6bd6efb…

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
28f9e201-7875-ea57-e063-6394a90a5e5557dbf5bb-d2b9-4a3a-e053-2a91aa0ae9712024-12-11WarningsExact identifier
spl id: 28f9e201-7875-ea57-e063-6394a90a5e55
spl set id: 57dbf5bb-d2b9-4a3a-e053-2a91aa0ae971

Reported adverse events (FAERS/openFDA)#

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