BARBIUX BALSAMIC TONIC 5%- minoxidil solution

Barbiux balsamic tonic 5% by

Drug Labeling and Warnings

Barbiux balsamic tonic 5% by is a Otc medication manufactured, distributed, or labeled by Incredible Products, S.A. de C.V., Incredible Products, S.A. de C.V. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient:

Minoxidil 5% w/v

Purpose:

Hair regrowth treatment for men

Use:

combat hair loss by reviving your hair follicles so you can safely and effectively experience hair regrowth.

Warnings:

For external use only. For use by men only.

Flammable: Keep away from fire or flame

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.

Directions:

• 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.

Questions?

• 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% 
minoxidil solution

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)