Label: BARBIUX BALSAMIC TONIC 5%- minoxidil solution
- NDC Code(s): 71761-260-60
- Packager: Incredible Products, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated July 3, 2019
If you are a consumer or patient please visit this version.
- Active ingredient:
Minoxidil 5% w/vClose
Hair regrowth treatment for menClose
combat hair loss by reviving your hair follicles so you can safely and effectively experience hair regrowth.Close
For external use only. For use by men only.
Flammable: Keep away from fire or flameClose
- Ask a doctor before use if you have: heart disease
- 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.
- Stop use and ask a doctor if
- chest pain, rapid heartbeat, faintness, or dizziness occurs
- sudden, unexplained weight gain occurs
- your hands or feet swell
- scalp irritation or redness occurs
- unwanted facial hair growth occurs
- you do not see hair regrowth in 4 months
- May be harmful if used when pregnant or breast-feeding.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
- 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
- Inactive ingredients:
Ricinus communis, Citrus bergamia, amino acids, mint extract, propylene glycol.Close
- call toll-free 800-764-2463 or 215-273-8755 (collect)
- visit www.rogaine.com
- Barbiux Tonic With Minoxidil 60 ml Incredible Products minoxidil
- INGREDIENTS AND APPEARANCE
BARBIUX BALSAMIC TONIC 5%
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71761-260 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 0.05 mg in 1 mL Inactive Ingredients Ingredient Name Strength RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) BERGAMOT ORANGE (UNII: IET5D90X0D) AMINO ACIDS (UNII: 0O72R8RF8A) PEPPERMINT (UNII: V95R5KMY2B) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71761-260-60 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/03/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 07/03/2019 Labeler - Incredible Products, S.A. de C.V. (815397500) Registrant - Incredible Products, S.A. de C.V. (815397500) Establishment Name Address ID/FEI Business Operations Incredible Products, S.A. de C.V. 815397500 manufacture(71761-260) , pack(71761-260) , label(71761-260)