NDC | 70788-580-01 |
Set ID | bffed457-967a-4afb-87c9-3e4e1285f04d |
Category | HUMAN OTC DRUG LABEL |
Packager | Premium Distribution, LLC |
Generic Name | |
Product Class | Arteriolar Vasodilator |
Product Number | |
Application Number | ANDA076239 |
- Drug Facts
- Active ingredient
- Purpose
- Use
- Warnings
-
Do not use if
- you are a woman
- 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. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline.
- 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, inflammed, infected, irritated, or painful
- you use other medicines on the scalp
- ASK DOCTOR
-
When using this product
- do not apply on other part of the body
- avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
- some individuals (people) have experienced changes in hair color and/or texture
- it takes time to regrow hair. Results may occur at 2 months with 2 times daily usage of this product. For some men, you may need to use this product 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 all men.
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- Prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
- apply 1 mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area
- using more or more often will not improve results
- continued use is necessary to increase and keep your hair regrowth or hair loss will begin again.
-
Other information
- see hair loss pictures on side of this carton
- before use, read all information on carton and enclosed booklet.
- keep the carton. It contains important information.
- hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solutions for men.
- In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth that 2% minoxidil topical solution.
- store at controlled room temperature 20° to 25° C (68° to 77° F)
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
REGEN
5% minoxidil topical solution solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70788-580 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 ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70788-580-01 1 in 1 CARTON 12/01/2016 1 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 12/01/2016 Labeler - Premium Distribution, LLC (079805390)