GROWELL WOMENS HAIR REGROWTH TREATMENT 2 MINOXIDIL- minoxidil liquid

GROWELL Womens Hair Regrowth Treatment 2 Minoxidil by

Drug Labeling and Warnings

GROWELL Womens Hair Regrowth Treatment 2 Minoxidil by is a Otc medication manufactured, distributed, or labeled by APIRA SCIENCE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair on the top of the scalp

Warnings:

For external use only. 

Flammable:Keep away from fire or flame

Do not use if:

• your degree of hair loss is different that than  shown on the side of this carton because this product may not work on you
• you have no family history of hair loss
• your hair loss is sudden and/or patchy
• your hair loss is associated with childbirth
• 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

Ask a doctor before use if you have

heart disease

When using this product

• do not apply on the 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. 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 everyone.

Stop use and ask a doctor if

• chest pain, rapid heartbeat, faintness, or dizziness occurs
• scalp irritation or redness occurs
• sudden, unexplained weight gain occurs
• unwanted facial hair growth occurs
• your hands or feet swell
• 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 Contrl Center right away.

Directions

• apply one mL with dropper 2 times a daydirectly on to 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 wil begin again

Other information

• See hair loss pictures on side of this carton
• before use, reatd 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 trials with continuous treatment with 5 % minoxidil topical solution for men
• in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: (19% of women reporting moderate hair regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
• store at controlled room temperature 20° to 25°C (68° to 77°F).

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

Call toll-free 1-(866)-982-7472

Visit our website at www.GroWellHair.com

Package Labeling:

INGREDIENTS AND APPEARANCE

GROWELL WOMENS HAIR REGROWTH TREATMENT 2 MINOXIDIL 
minoxidil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84329-466
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	20 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: 84329-466-00	1 in 1 BOX	03/04/2024
1		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078176	03/04/2024

Labeler - APIRA SCIENCE, INC. (010514721)