Label: MENS RAPID REINVENT 5 MINOXIDIL SOLUTION- minoxidil liquid
- NDC Code(s): 83719-427-00
- Packager: THE SELF AND BODY LOVE COMPANY LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 4, 2023
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- 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 hairloss 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, 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 hari 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 trails with continuous treatment with 5% minoxidil topical solution for men • in clinical studies of mostly white men aged 18-49 years with moderate degree 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
MENS RAPID REINVENT 5 MINOXIDIL SOLUTION
minoxidil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83719-427 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:83719-427-00 1 in 1 BOX 10/16/2023 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 10/16/2023 Labeler - THE SELF AND BODY LOVE COMPANY LLC (119082300)