Label: MINOXIGAINE- minoxidil liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 72965-001-01 - Packager: Hairgenics LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated March 26, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
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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)