MINOXIGAINE- minoxidil liquid

MINOXIGAINE by

Drug Labeling and Warnings

MINOXIGAINE by is a Otc medication manufactured, distributed, or labeled by Hairgenics LLC, PHARMA-NATURAL INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 5%

PURPOSE

Hair Regrowth Treatment for Men

INDICATIONS & USAGE

WARNINGS

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

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

Questions or comments:
1-281-454-3563

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINOXIGAINE 
minoxidil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72965-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72965-001-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2019

Labeler - Hairgenics LLC (108751481)

Registrant - PHARMA-NATURAL INC. (138059287)

Establishment
Name	Address	ID/FEI	Business Operations
PHARMA-NATURAL INC.		138059287	manufacture(72965-001)