Label: FOLLICLE FOLLIXIL 5% MINOXIDIL HAIR REGROWTH-LOTION liquid
- NDC Code(s): 84148-005-01
- Packager: Guangzhou Ariel Biotech Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 17, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
-
Do not use
●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. Minoxidil topical solution 5% 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, iritated 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 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
- KEEP OUT OF REACH OF CHILDREN
- Directions
-
Other information
1.See hair loss pictures on side of this carton.
2.Before use, read all information on carton and enclosed leaflet.
3.Keep the carton. It contains important information.
4.Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil
topical solution 5% for men.
5.In clinical studies with mostly white men aged between 18-49 years with moderate degrees of hair loss, monoxidil topical
solution 5% for men provided more hair regrowth than minoxidil topical solution 2%,
6.Store at 20° to 259C (68° to 77°F). Keep tightly closed. - Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
FOLLICLE FOLLIXIL 5% MINOXIDIL HAIR REGROWTH-LOTION
follicle follixil 5% minoxidil hair regrowth-lotion liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84148-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 5 mg in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) BIOTIN (UNII: 6SO6U10H04) NIACINAMIDE (UNII: 25X51I8RD4) CAFFEINE (UNII: 3G6A5W338E) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84148-005-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/17/2024 Labeler - Guangzhou Ariel Biotech Co., Ltd. (402818771) Establishment Name Address ID/FEI Business Operations Guangzhou Ariel Biotech Co., Ltd. 402818771 manufacture(84148-005)