NDC | 72965-001-01 |
Set ID | e642a352-4387-404d-b090-789687884b9e |
Category | HUMAN OTC DRUG LABEL |
Packager | Hairgenics LLC |
Generic Name | |
Product Class | Arteriolar Vasodilator |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- PURPOSE
- 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
- Directions
- Other Information
- Other Ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MINOXIGAINE
minoxidil liquidProduct 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)