Label: FINALLY HAIR MINOXIDIL 5% HAIR GROWTH FOAM (hair growth foam- serum liquid
- NDC Code(s): 81653-011-01
- Packager: Guangzhou Jianyuan Biological Technology Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
-
Do not use
■ you are a pregnant woman
■ 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
■ 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 people, 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 people. - Stop Use
- Ask Doctor
- Keep Oot Of Reach Of Children
-
Directions
■ apply right amount directly to the scalp in the hair loss area.
■ massage into scalp with fingers, then wash hands well.
■ 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.
For best results: Keep using (Men use twice a daily. Women use once a day). -
Other information
■ see hair loss pictures on side of this carton
■ before use, read all information on carton
■ 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 Hair Regrowth Treatment for men and women
■ In clinical studies with mostly white men and women aged 18-49 years with moderate degrees of hair loss, Hair Regrowth Treatment for people provided more hair regrowth than minoxidil topical solution 2%
■ store at 20° to 25°C (68° to 77°F). Keep tightly closed. - Inactive ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FINALLY HAIR MINOXIDIL 5% HAIR GROWTH FOAM
hair growth foam (serum) liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81653-011 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 NIACINAMIDE (UNII: 25X51I8RD4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) COLLAGEN ALPHA-1(I) CHAIN BOVINE (UNII: FB3DQM32F2) METHYLPARABEN (UNII: A2I8C7HI9T) TETRAMETHYLCHROMANOL GLUCOSIDE (UNII: 7YWI9T8733) ADENOSINE (UNII: K72T3FS567) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81653-011-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075357 12/08/2023 Labeler - Guangzhou Jianyuan Biological Technology Co.,Ltd (548120189) Establishment Name Address ID/FEI Business Operations Guangzhou Jianyuan Biological Technology Co.,Ltd 548120189 manufacture(81653-011)