Label: NAVI HAIR SOLUTIONS WOMENS HAIR REGROWTH TREATMENT- minoxodil 2% solution
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Contains inactivated NDC Code(s)
NDC Code(s): 82524-001-01 - Packager: United Distribution of MD, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 21, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
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DO NOT USE
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 - ASK DOCTOR
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WHEN USING
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.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
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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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAVI HAIR SOLUTIONS WOMENS HAIR REGROWTH TREATMENT
minoxodil 2% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82524-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82524-001-01 1 in 1 BOX 01/21/2022 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078176 01/21/2022 Labeler - United Distribution of MD, LLC (030345600)