![MINOXIDIL SOLUTION [HI-TECH PHARMACAL CO., INC.]](https://medic.hrt.org//dailymed/images/1c548d51-6c30-4d82-a572-76f83f2d6a95/image-01.jpg)
| NDC | 50383-001-02 |
| Set ID | 1c548d51-6c30-4d82-a572-76f83f2d6a95 |
| 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
- Keep Out of Reach of Children
- Uses
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Warnings
For external use only
Flammable: Keep away from fire or flame
Do no use if
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- your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 2% is not intended for frontal baldness or receding hairline.
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- you have no family history of hair loss
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- your hair loss is sudden and/or patchy
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- you do not know the reason for your hair loss
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- you are under 18 years of age. Do not use on babies and children.
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- your scalp is red, inflamed, infected, irritated, or painful
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- you use other medicines on the scalp
When using this product
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- do not apply on other parts of the body
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- avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
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- some people have experienced changes in hair color and/or texture
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- 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.
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- the amount of hair regrowth is different for each person. This product will not work for everyone
- Directions
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Other Information
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- see hair loss pictures on side of this carton
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- before use, read all information on carton and enclosed insert
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- keep the carton. It contains important information.
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- In clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, the following response to minoxidil topical solution was reported: 26% of men reported moderate to dense hair regrowth after using minoxidil topical solution for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). This compares with 11% of men reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 4 months (11% had moderate to dense regrowth; 31% had minimal regrowth).
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- store at controlled room temperature 20° to 25°C (68° to 77°F)
- Inactive Ingredients
- Questions or comments?
- PackageLabel Principal Display Panel
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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:50383-001-02 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)
