Label: HAIR LABS MENS EXTRA STRENGTH 5 MINOXIDIL- minoxidil liquid
- NDC Code(s): 83454-404-00
- Packager: HAIR RESTORATION LABS, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 11, 2023
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 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 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 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 20° to 25° C (68° to 77°F).
- Inactive ingredients
- Questions or comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
HAIR LABS MENS EXTRA STRENGTH 5 MINOXIDIL
minoxidil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83454-404 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:83454-404-00 1 in 1 BOX 05/15/2023 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 05/15/2023 Labeler - HAIR RESTORATION LABS, LLC (089765024)
