NDC | 71517-001-01, 71517-001-02 |
Set ID | 53f66d84-c5b2-1a90-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Nutrastim Hair LLC |
Generic Name | |
Product Class | Arteriolar Vasodilator |
Product Number | |
Application Number | ANDA075598 |
- PURPOSE
- WARNINGS
-
DO NOT USE
- 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.
- Your hair loss is associated with child birth.
- 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.
- ASK DOCTOR
-
WHEN USING
- 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. Results may occur at 2 months with twice a day usage. For some women, you may need to use this product for at least 4 months before you see results.
- The amount of hair regrowth is different with each person. This product will not work for all women.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
-
Other information
- Before use see hair loss pictures on side of this box.
- Keep the box, 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 minoxidil topical solution was 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% 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 20° to 25° C (68° to 77° F).
Keep tightly closed.
- INACTIVE INGREDIENT
- QUESTIONS
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MINOXIDIL SOLUTION
minoxidil solution solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71517-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 20 g in 1 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:71517-001-02 2 in 1 CARTON 06/29/2017 1 NDC:71517-001-01 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075598 06/29/2017 Labeler - Nutrastim Hair LLC (080274282)