Label: DAW MINOXIDIL TOPICAL SOLUTION MENS HAIR REGROWTH TREATMENT 5- minoxidil liquid
- NDC Code(s): 82372-482-00
- Packager: Good Manager Holdings Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 1, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Use
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Warnings
For external use only. For use by men only.
Flammable:Keep away from fire or flame
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, inflamed, infected, irritated or painful
- you use other medicines on the scalp
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 amount of cool tap water
- some people have experienced changes in hair colour 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.
- Directions
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Other information
- 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 tratment 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
- Inactive ingredients:
- Questions or comments?
- Package Labelling:
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INGREDIENTS AND APPEARANCE
DAW MINOXIDIL TOPICAL SOLUTION MENS HAIR REGROWTH TREATMENT 5
minoxidil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82372-482 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:82372-482-00 1 in 1 BOX 05/06/2024 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 05/06/2024 Labeler - Good Manager Holdings Inc (118382673)
