NAVI HAIR SOLUTIONS WOMENS HAIR REGROWTH TREATMENT- minoxodil 2% solution 
United Distribution of MD, LLC

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Navi Hair Solutions Women's Hair Regrowth Treatment

Minoxidil 2% w/v

Hair regrowth treatment

USE

Use to regrow hair on the top of the scalp

For external use only.

Flamable: Keep away from fire of flame.

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 a doctor before use if you have heart disease

When using this product

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.

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

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)

Alcohol, Propylene Glycol, Purified Water

Questions or comments? 1-800-924-0978 customerservice@navihair.com

Visit our website at www.navihair.com

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NAVI HAIR SOLUTIONS WOMENS HAIR REGROWTH TREATMENT 
minoxodil 2% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82524-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82524-001-011 in 1 BOX01/21/2022
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07817601/21/2022
Labeler - United Distribution of MD, LLC (030345600)

Revised: 1/2022
Document Id: d62022fa-e1d6-2467-e053-2a95a90a802d
Set id: d62022fa-e1d5-2467-e053-2a95a90a802d
Version: 1
Effective Time: 20220121
 
United Distribution of MD, LLC