MINOXIGAINE- minoxidil liquid 
Hairgenics LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Minoxidil 5%

Hair Regrowth Treatment for Men

For external use only. 
Flammable: Keep away from fire or flame
Do not use if:
• 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 and children
• Your scalp is red, inflamed, 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 tap water
• Some people have experienced changes in hair color and/or texture    it takes time to regrow hair. 
• You may need to use this product 2 times a day for at least 4 months before you see results
• The amount of hair regrowth is different for each person.
• This product may not work for everyone.
Stop use and/or ask a doctor if
• Chest pain, rapid heartbeat, faintness, dizziness or 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 is 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

Using dropper, apply one mL directly onto the scalp in the hair loss area

For best results use twice daily on dry towel dried hair.

Use fingertips to massage solution into skin

Other Information

• Store at controlled room temperature 68º to 77ºF (20º- 25ºC)

Other Ingredients

Azelaic Acid, Retinol, Caffeine, Biotin, Saw Palmetto Extract, Nettle Extract 10:1, Pygeum Bark Extract, Water, SD Alcohol, Propylene Glycol, Gransolve DMI, Fresh Blue Agave, Zinc Sulfate, Vitamin B6.

Questions or comments:
1-281-454-3563

PRINCIPAL DISPLAY PANEL

Minoxigaine

MINOXIGAINE 
minoxidil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72965-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AZELAIC ACID (UNII: F2VW3D43YT)  
RETINOL (UNII: G2SH0XKK91)  
CAFFEINE (UNII: 3G6A5W338E)  
BIOTIN (UNII: 6SO6U10H04)  
SAW PALMETTO (UNII: J7WWH9M8QS)  
URTICA DIOICA (UNII: 710FLW4U46)  
PYGEUM (UNII: 709HYI14M4)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)  
ZINC SULFATE (UNII: 89DS0H96TB)  
PYRIDOXINE (UNII: KV2JZ1BI6Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72965-001-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/2019
Labeler - Hairgenics LLC (108751481)
Registrant - PHARMA-NATURAL INC. (138059287)
Establishment
NameAddressID/FEIBusiness Operations
PHARMA-NATURAL INC.138059287manufacture(72965-001)

Revised: 3/2019
Document Id: 7bfb9e1a-e6c7-4ed4-9148-87717ef6a295
Set id: e642a352-4387-404d-b090-789687884b9e
Version: 1
Effective Time: 20190326
 
Hairgenics LLC