![MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]](https://medic.hrt.org//dailymed/images/15caf429-1ce2-4306-9cff-54d04335ebb3/d5595f80-3f73-4f16-a701-1e4276b68b5e-01.jpg)
| NDC | 50383-001-20 |
| Set ID | 15caf429-1ce2-4306-9cff-54d04335ebb3 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Hi-Tech Pharmacal Co., Inc. |
| Generic Name | |
| Product Class | Arteriolar Vasodilator |
| Product Number | |
| Application Number | ANDA074731 |
- Active ingredient
- Purpose
- Use
-
Warnings
For external use only
Flammable: Keep away from fire or flame
Do no use if
- •
- your degree of hair loss is different than that 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
- •
- 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, infected, irritated, or painful
- •
- you use other medicines on the scalp
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 cool 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 will not work for everyone.
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.
- Directions
-
Other Information
- •
- see hair loss pictures on side of this carton
- •
- before use, read all information on carton and enclosed insert
- •
- keep the carton. It contains important information.
- •
- In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution 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 regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
- •
- store at controlled room temperature 20° to 25°C (68° to 77°F)
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
MINOXIDIL
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50383-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 2 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50383-001-20 1 in 1 CARTON 12/24/1996 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074731 12/24/1996 Labeler - Hi-Tech Pharmacal Co., Inc. (117696873) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Hi-Tech Pharmacal Co., Inc. 117696873 MANUFACTURE(50383-001)
