Label: DANIEL ALAIN EXTRA STRENGTH HAIR REGROWTH TREATMENT FOR MEN- minoxidil 5% solution
- NDC Code(s): 82545-002-01
- Packager: Daniel Alain, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 4, 2022
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
DO NOT USE
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% 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 or children
- Your scalp is red, inflammed, infected, irritated, or painful
- You use other medicines on your scalp
- ASK DOCTOR
When using this product
- Do not apply on other parts of the body
- Avoid contact with eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
- Some people have experienced change 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 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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
• See hair loss pictures on side of this carton
• Before use, read all information on carton and enclosed leaflet
• 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 solution for men
• in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
• Store at controlled room temperature 68º to 77ºF (20º to 25ºC).
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
DANIEL ALAIN EXTRA STRENGTH HAIR REGROWTH TREATMENT FOR MEN
minoxidil 5% solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82545-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82545-002-01 1 in 1 BOX 02/04/2022 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 ANDA076239 02/04/2022 Labeler - Daniel Alain, Inc (010990313)