Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Minoxidil 5% w/v
OTC - PURPOSE SECTION
Hair regrowth treatment for men
GROFULLY 5% Minoxidil Topical Solution
- Manufacturer
- TTEM, Inc
- Effective date
- 2022-01-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:47:32
Key Label Information#
Uses
USE
to regrow hair on the top of the scalp (vertex only, see picture on side on carton)
Warnings
WARNINGS SECTION
For external use only. Flammable: Keep away from fire or flame.
OTC - DO NOT USE SECTION
Do not use if 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. 5% topical solution 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 or children. Your scalp is red, inflammed, infected, irritated, or painful You use other medicines on your scalp
OTC - PREGNANCY OR BREAST FEEDING SECTION
May be harmful if used when pregnant or breast-feeding.
Directions And Dosage
DIRECTIONS
• Apply one mL with dropper 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 to increase and keep your hair regrowth, or hair loss will begin again.
Other Label Information
INACTIVE INGREDIENT SECTION
Alcohol, Propylene Glycol, Purified Water
OTC - QUESTIONS SECTION
Questions or comments Call toll-free 1-800-559-7691 or visit grofully.com
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MINOXIDIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70150-007-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0af2-111a-e063-dadaa90a10e2 | GROFULLY 5% Minoxidil Topical Solution |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70150-007-01 | GROFULLY Mens Extra Strength Hair Regrowth Treatment | 1 in 1 BOX | SOLUTION | 1 | 1 | |
| 70150-007-01 | GROFULLY Mens Extra Strength Hair Regrowth Treatment | 60 mL in 1 BOTTLE | SOLUTION | 60 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
- GROFULLY Mens Extra Strength Hair Regrowth Treatment
- Minoxidil 5%
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70150-007 | 70150-007-01 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| MINOXIDIL | 5965120SH1 | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| WATER | 059QF0KO0R | IACT |
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Minoxidil 5% w/v
OTC - PURPOSE SECTION
Hair regrowth treatment for men
USE
to regrow hair on the top of the scalp (vertex only, see picture on side on carton)
WARNINGS SECTION
For external use only. Flammable: Keep away from fire or flame.
OTC - DO NOT USE SECTION
Do not use if 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. 5% topical solution 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 or children. Your scalp is red, inflammed, infected, irritated, or painful You use other medicines on your scalp
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have heart disease
OTC - WHEN USING SECTION
When using this product Do not apply on other parts of the body Avoid contact with eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. Some people have experienced change 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.
OTC - STOP USE SECTION
Stop use and ask 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
May be harmful if used when pregnant or breast-feeding.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poison Control Center right away.
DIRECTIONS
• Apply one mL with dropper 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 to increase and keep your hair regrowth, or hair loss will begin again.
Other 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 regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men • in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution • Store at controlled room temperature 68º to 77ºF (20º to 25ºC).
INACTIVE INGREDIENT SECTION
Alcohol, Propylene Glycol, Purified Water
OTC - QUESTIONS SECTION
Questions or comments Call toll-free 1-800-559-7691 or visit grofully.com