Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Minoxidil 2% w/v
OTC - PURPOSE SECTION
Hair regrowth treatment
Navi Hair Solutions Womens Hair Regrowth Treatment
- Manufacturer
- United Distribution of MD, LLC
- Effective date
- 2022-01-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:47:32
Key Label Information#
Uses
USE
Use to regrow hair on the top of the scalp
Warnings
WARNINGS SECTION
For external use only. Flamable: Keep away from fire of flame.
OTC - DO NOT USE SECTION
Do not use if: Your amount of hair loss is different than shown on the side of this carton, because this product may not work for you You have no family history of hair loss Your hair loss is sudden and/or patchy Your hair loss is associated with childbirth 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, inflamed, infected, irritated, or painful You use other medicines on the 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 ofthen 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? 1-800-924-0978 customerservice@navihair.com Visit our website at www.navihair.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 |
|---|---|---|---|---|---|
| 82524-001-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2157-111a-e063-dadaa90a10e2 | Navi Hair Solutions Women's Hair Regrowth Treatment |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82524-001-01 | Navi Hair Solutions Womens Hair Regrowth Treatment | 1 in 1 BOX | SOLUTION | 1 | 1 | |
| 82524-001-01 | Navi Hair Solutions Womens Hair Regrowth Treatment | 60 mL in 1 BOTTLE | SOLUTION | 60 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
- Navi Hair Solutions Womens Hair Regrowth Treatment
- Minoxodil 2%
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82524-001 | 82524-001-01 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| MINOXIDIL | 5965120SH1 | ACTIB |
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Minoxidil 2% w/v
OTC - PURPOSE SECTION
Hair regrowth treatment
USE
Use to regrow hair on the top of the scalp
WARNINGS SECTION
For external use only. Flamable: Keep away from fire of flame.
OTC - DO NOT USE SECTION
Do not use if: Your amount of hair loss is different than shown on the side of this carton, because this product may not work for you You have no family history of hair loss Your hair loss is sudden and/or patchy Your hair loss is associated with childbirth 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, 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
OTC - WHEN USING SECTION
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 expereinced changes in hair color and/or texture It takes time to re-grow hair. 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 women.
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
DIRECTIONS
Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area Using more or more ofthen will not improve results Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
OTHER SAFETY INFORMATION
See hair loss pictures on the side of this carton Before use, read all information on carton and enclosed leaflet Keep the carton. It contains important information In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses to Minoxidil Topical Solution 2% was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal hair regrowth). This compares with the 7% of women reporting moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth). Store at controlled room temperature 20 o to 25 o C (68 o to 77 oF)
INACTIVE INGREDIENT SECTION
Alcohol, Propylene Glycol, Purified Water
OTC - QUESTIONS SECTION
Questions or comments? 1-800-924-0978 customerservice@navihair.com Visit our website at www.navihair.com